GlucoSensor™ Q
Version: V010726
Effective date: 1 July 2026
Issued by: Maralvion sp. z o.o.
Applicable product: GlucoSensor™ Q Continuous Glucose Monitoring System, Model D1
Website: www.glucosensor.com
Contact: support@glucosensor.com
ARTICLE 1. DEFINITIONS
1.1 In these General Delivery Terms, the following terms have the meanings set out below. These Terms form part of the broader GlucoSensor™ Q legal framework, together with the Legal Documents defined in Article 1.21.
1.2 Capitalised terms used but not defined in these Terms have the meaning given to them in the Privacy Policy, the App EULA, the Instructions for Use, Product labelling, applicable mandatory Product information or applicable law, as relevant to the subject matter and unless the context clearly requires otherwise.
1.3 “Account” means a user account created or used through the Website, webshop, App or related account environment to place or manage orders, access the App, manage support features, submit requests or use related GlucoSensor™ Q services.
1.4 “App” means the GlucoSensor™ Q mobile application made available by or on behalf of Maralvion for use with the GlucoSensor™ Q System, including the user interface, account environment, Sensor connection functionality, alerts, reports, support functionality, updates and related digital features.
1.5 “App EULA” means the App End User License Agreement for the GlucoSensor™ Q App.
1.6 “Authorised Representative” means Firsteck Bio S.r.l., Via Salvatore Quasimodo 36/38, 40013 Castel Maggiore, Italy, acting as authorised representative of the Manufacturer within the European Union where and to the extent indicated in the applicable regulatory documentation.
1.7 “Authorised Service Providers” means third party service providers engaged by Maralvion to support orders, payments, fulfilment, logistics, customer support, technical support, hosting, authentication, marketing, analytics, accounting, legal, regulatory, compliance or administrative services.
1.8 “Business Customer” means a Customer acting for business, professional, commercial, institutional, clinical, resale, procurement or other non consumer purposes.
1.9 “Consumer” means a natural person acting for purposes that are wholly or mainly outside that person’s trade, business, craft or profession.
1.10 “Customer” means the person or entity placing an order for GlucoSensor™ Q through an Official GlucoSensor Sales Channel.
1.11 “Customer Support” means support provided through official GlucoSensor support channels, including support by Maralvion or by Authorised Service Providers acting on behalf of Maralvion.
1.12 “Device” means the GlucoSensor™ Q System where that term is used in the context of CE marking, medical device law, the certificate, Product labelling, the Instructions for Use, manufacturer approved regulatory documentation or mandatory Product information.
1.13 “Digital Content Laws” means applicable EU and national consumer protection rules on contracts for the supply of digital content, digital services or goods with digital elements, including national laws implementing Directive (EU) 2019/770 and Directive (EU) 2019/771 where and to the extent applicable.
1.14 “Dreisam” or “Manufacturer” means Dreisam (Beijing) Medical Technology Co., Ltd., Liangshuihe 1st Street, Room 101, 1F, Building 9, Zone 1, Court 7, Beijing 100176, P.R.C., as legal manufacturer of the GlucoSensor™ Q System.
1.15 “General Delivery Terms” or “Terms” means these General Delivery Terms for the sale and delivery of GlucoSensor™ Q.
1.16 “GlucoSensor” or “GlucoSensor™ Q” means the GlucoSensor brand, the GlucoSensor™ Q System, the Product, the App, the Website or a related GlucoSensor service, depending on the context.
1.17 “GlucoSensor™ Q System” or “System” means the CE marked Class IIb GlucoSensor™ Q Continuous Glucose Monitoring system, Model D1, manufactured by Dreisam and made available by Maralvion under the GlucoSensor™ Q brand in selected European markets. The System consists of the Sensor and the App and is intended to be used in accordance with the Instructions for Use, Product labelling and applicable Product information.
1.18 “Instructions for Use” or “IFU” means the manufacturer approved instructions, warnings, precautions, contraindications, operating requirements, storage requirements, troubleshooting instructions, disposal instructions and other safety information supplied with or made available for GlucoSensor™ Q.
1.19 “Manufacturer SDK” means the manufacturer supplied or manufacturer authorised software components, interfaces, communication protocols and related technical components used in connection with the App and the GlucoSensor™ Q System to support Sensor communication, glucose related functionality and related System operation, as supplied, authorised or specified by Dreisam.
1.20 “Maralvion”, “we”, “us” or “our” means Maralvion sp. z o.o., Pl. Władysława Andersa 3, 11th Floor, 61-894 Poznań, Poland, registered in the Polish National Court Register under KRS 0001235440, NIP 7831951730 and REGON 544505977.
1.21 “Legal Documents” means these Terms, the Website EULA and Terms of Use, the App EULA, the Privacy Policy, the Returns and Refund Policy, the Sensor Replacement Policy, the Legal Disclaimer for the GlucoSensor™ Q App, the Website Legal Disclaimer and any other legal terms or policies published by Maralvion for GlucoSensor™ Q.
1.22 “MDR” means Regulation (EU) 2017/745 on medical devices.
1.23 “Official GlucoSensor Sales Channels” means the Website, webshop and any other sales channel expressly identified or approved by Maralvion for the sale of GlucoSensor™ Q.
1.24 “Privacy Policy” means the GlucoSensor™ Q Privacy Policy published by Maralvion.
1.25 “Product” means the physical GlucoSensor™ Q product supplied to the Customer, consisting of one Sensor supplied in its applicator, the Instructions for Use, the Quick Guide, one adhesive patch and the related Product packaging and labelling.
1.26 “Quick Guide” means the brief user guidance supplied in the Product packaging. The Quick Guide does not replace the IFU.
1.27 “Returns and Refund Policy” means the GlucoSensor™ Q Returns and Refund Policy published by Maralvion.
1.28 “Sensor” means the disposable GlucoSensor™ Q sensor assembly supplied in its applicator and intended to be applied, activated, worn, used, removed and replaced in accordance with the Instructions for Use. The applicator is supplied to place the Sensor and is not a separate reusable System component. The Sensor is a single use component of the GlucoSensor™ Q System and is intended for a maximum wear period of 14 days where the applicable conditions of use are met.
1.29 “Sensor Replacement Policy” means the GlucoSensor™ Q Sensor Replacement Policy published by Maralvion.
1.30 “Sensor Serial Number” means the unique Sensor code, QR code or manual code printed on or supplied with the Sensor and used to pair or activate that Sensor with the App. The Sensor Serial Number is not the same as the lot number on the Product packaging.
1.31 “Serious Incident” means a serious incident within the meaning of applicable EU medical device law, including an incident related to GlucoSensor™ Q that directly or indirectly led, might have led or might lead to death or serious deterioration in health.
1.32 “User” means the individual who uses GlucoSensor™ Q or the App. The Customer and the User may be the same person, but they are not always the same person.
1.33 “Website” means the GlucoSensor website, webshop and related online account environment operated by or on behalf of Maralvion at www.glucosensor.com.
1.34 “Website EULA and Terms of Use” means the Website EULA and Terms of Use published by Maralvion for the Website.
ARTICLE 2. SCOPE, ACCEPTANCE AND LEGAL FRAMEWORK
2.1 These Terms govern the sale and delivery of physical Products purchased through Official GlucoSensor Sales Channels and related commercial matters, including order handling, payment, delivery, receipt, subscription deliveries, delivery complaints, statutory conformity claims, product complaints and customer support matters.
2.2 Returns, refunds and Sensor replacement requests are addressed in these Terms only to the extent necessary to explain their relationship with the sale and delivery of Products. Return eligibility, refund procedures and withdrawal procedures are governed primarily by the Returns and Refund Policy. Sensor replacement eligibility and replacement procedures are governed primarily by the Sensor Replacement Policy.
2.3 These Terms do not by themselves grant a licence to use the Website or the App and do not govern the processing of Personal Data except where these Terms refer to the Privacy Policy.
2.4 The use of the Website is governed by the Website EULA and Terms of Use. The use of the App is governed by the App EULA and the Legal Disclaimer for the GlucoSensor™ Q App. The processing of Personal Data is governed by the Privacy Policy.
2.5 These Terms form part of the broader GlucoSensor™ Q legal framework. The Customer and User must also read and comply with the applicable Legal Documents, the IFU, Product labelling, safety notices and mandatory Product information.
2.6 In the event of inconsistency between these Terms and another applicable Legal Document, the document that most specifically addresses the relevant subject matter prevails for that subject matter. Product use, safety, contraindications, precautions, warnings, performance specifications and medical device instructions are primarily governed by the IFU, Product labelling, mandatory safety information and applicable legal disclaimers. App access, App functionality, digital content, digital services and App related digital conformity are primarily governed by the App EULA, subject to mandatory rights relating to goods with digital elements where applicable. Privacy and data protection matters are primarily governed by the Privacy Policy. Return eligibility and refund procedures are primarily governed by the Returns and Refund Policy. Sensor replacement eligibility and replacement procedures are primarily governed by the Sensor Replacement Policy.
2.7 Nothing in these Terms limits, excludes or restricts mandatory rights, remedies, obligations or liabilities under applicable consumer protection law, product liability law, medical device law, data protection law, product safety law, Digital Content Laws or any other mandatory applicable law.
2.8 Maralvion offers and supplies Products only in countries where it chooses and is able to make GlucoSensor™ Q lawfully available. Maralvion may refuse, suspend or cancel orders where sale, delivery, import, export, payment, support or use is not legally, commercially, logistically or practically possible.
2.9 By placing an order, the Customer confirms that these Terms and the applicable Legal Documents made available through the Website, checkout process or another applicable official channel have been made available to the Customer and, where legally valid, that the Customer accepts them.
ARTICLE 3. COMMERCIAL AND REGULATORY ROLES
3.1 Maralvion is the seller, contracting party, EU importer, inventory holder, order fulfilment party and customer facing commercial operator for Products sold through Official GlucoSensor Sales Channels, unless another official seller is expressly identified at checkout.
3.2 Dreisam is the legal manufacturer of the GlucoSensor™ Q System and remains responsible within its manufacturer role for System design, manufacture, conformity assessment, CE marking, technical documentation, clinical performance, Sensor technology, the Manufacturer SDK, manufacturer supplied or manufacturer authorised software components, post market surveillance, vigilance and other manufacturer obligations under applicable medical device law.
3.3 Firsteck Bio S.r.l. acts as the Authorised Representative of the Manufacturer within the European Union where and to the extent indicated in the applicable regulatory documentation.
3.4 Maralvion performs the obligations assigned to it as seller, EU importer and customer facing economic operator under applicable law, including order handling, delivery handling, importer related checks, complaint handling, customer support and cooperation with the Manufacturer and Authorised Representative where required.
3.5 Maralvion may use Authorised Service Providers for fulfilment, logistics, payment processing, hosting, authentication, customer support, technical support, marketing, analytics, accounting, legal, regulatory, compliance and administrative services. Such service providers do not become sellers, importers, manufacturers, authorised representatives or contracting parties toward the Customer or User solely because they provide services to or on behalf of Maralvion.
3.6 Maralvion may operate, configure, localise and maintain App elements relating to the Account environment, user interface, language versions, support flows, content, notifications, visual presentation, customer communications and related user experience elements. Maralvion does not independently design, manufacture, alter or replace the Sensor, the Manufacturer SDK or the manufacturer supplied or manufacturer authorised functionality used to generate glucose related information.
3.7 Nothing in these Terms transfers the regulatory responsibilities of the Manufacturer to Maralvion, the Customer, the User or any Authorised Service Provider, except to the extent mandatory law imposes specific obligations on Maralvion within its own role as seller, EU importer, App operator, customer support provider or economic operator.
3.8 Customer Support may provide product, order, delivery, technical, safety and general use information. Customer Support does not provide medical advice, diagnosis, treatment advice, clinical interpretation, medication advice, insulin dosing advice, emergency assistance, professional monitoring or professional healthcare services.
ARTICLE 4. PRODUCT INFORMATION
4.1 GlucoSensor™ Q is a CE marked Class IIb Continuous Glucose Monitoring System, Model D1, manufactured by Dreisam and made available by Maralvion under the GlucoSensor™ Q brand in selected European markets. The System consists of the Sensor and the App. The Sensor is supplied in an applicator that is used to place the Sensor.
4.2 GlucoSensor™ Q uses an integrated sensor design. The Product does not include a separate reusable transmitter.
4.3 Each Product package contains one Sensor supplied in its applicator, the Instructions for Use, the Quick Guide, one adhesive patch and the related Product packaging and labelling.
4.4 Each Sensor is intended for single use and for a maximum wear period of 14 days. The actual usable wear period may be shorter where required by the IFU, Product expiry, Sensor detachment, failed placement, failed activation, App notifications, skin reaction, technical malfunction, safety concern or another use condition.
4.5 GlucoSensor™ Q is intended to be used with the App as part of the GlucoSensor™ Q System. Proper use may require a compatible mobile device, the App, Bluetooth, internet access during registration or setup, an Account, required device permissions and enabled notifications.
4.6 Product information on the Website, in marketing materials, on Product pages, in emails, in customer support communications or in other commercial materials is provided to assist Customers and Users. For matters relating to official intended purpose, target population, indications, contraindications, warnings, limitations, CE marking, Product identification, performance specifications and safe and correct Product use, the IFU, Product labelling, mandatory safety information and manufacturer approved documentation prevail for that subject matter only. This does not make the IFU the controlling document for commercial terms, privacy, App licensing, refund procedures, Sensor replacement procedures, dispute handling or other legal matters governed by the relevant Legal Documents.
4.7 Maralvion makes reasonable efforts to ensure that Product descriptions, images, prices, availability information and essential Product information are accurate. Minor variations in packaging, presentation, language versions, images, screenshots, non essential design elements or support materials may occur, provided that such variations do not affect statutory conformity, safety or essential Product characteristics.
4.8 The availability of GlucoSensor™ Q does not mean that the Product is reimbursed, prescribed, recommended or covered by a healthcare system, insurer, healthcare professional or public authority in the Customer’s country. Customers and Users are responsible for checking any reimbursement, prescription or healthcare coverage requirements that may apply to them.
ARTICLE 5. ELIGIBILITY, PERSONAL USE AND USE RESTRICTIONS
5.1 GlucoSensor™ Q is intended for adults aged 18 years and older. By ordering the Product, the Customer confirms that the intended User is at least 18 years old.
5.2 GlucoSensor™ Q must not be used by persons under 18 years of age.
5.3 Unless expressly agreed otherwise in writing, Products sold through the Website are supplied for personal use only. They are not supplied for resale, redistribution, relabelling, repackaging, modification, clinical trial use, institutional procurement, professional healthcare procurement or commercial exploitation.
5.4 The Customer must not resell, redistribute, export, repackage, relabel, translate, modify or otherwise make GlucoSensor™ Q available to third parties as a commercial product without Maralvion’s prior written consent and without complying with all applicable medical device, consumer protection, product safety, data protection, tax, customs and advertising laws.
5.5 The Customer and User must not remove, obscure, alter, translate, replace or add to the Product labelling, IFU, Quick Guide, packaging, UDI information, lot information, Sensor Serial Number, manufacturer information, importer information, Authorised Representative information, CE marking, warnings or safety information.
5.6 The User must use GlucoSensor™ Q only in accordance with the IFU, Product labelling, App instructions, safety warnings, contraindications, precautions and applicable medical guidance.
5.7 The User must not use the Product if the packaging is damaged, opened, compromised, expired, contaminated, incorrectly stored, exposed to conditions outside the Product labelling or suspected to be unsafe or non conforming.
5.8 The User must not use GlucoSensor™ Q with unauthorised third party software, unauthorised data interpretation tools, automated insulin dosing systems, closed loop systems, insulin suspension systems or other connected medical systems, unless such use is expressly authorised by the Manufacturer and permitted under the applicable regulatory documentation.
ARTICLE 6. ORDERING PROCESS AND CONTRACT FORMATION
6.1 Products may be ordered through the Website, webshop or another Official GlucoSensor Sales Channel expressly made available or approved by Maralvion.
6.2 Product pages, promotional materials, Website content and other commercial information are invitations to place an order. A binding sales contract is formed only in accordance with Article 6.5, unless mandatory law provides otherwise.
6.3 The Customer is responsible for providing complete, accurate and current order information, including name, billing address, delivery address, email address, telephone number where required, payment information and any other information necessary to process and deliver the order.
6.4 Before placing an order, the Customer will have the opportunity to review the selected Products, quantity, total price, applicable VAT, shipping costs, delivery details, payment method and other essential order details. Where required by applicable law, the final order button or equivalent order confirmation step will clearly indicate that placing the order creates an obligation to pay.
6.5 The order is placed when the Customer completes the checkout process and submits the order. The sales contract between the Customer and Maralvion is formed when Maralvion sends the order confirmation by email, unless mandatory law provides otherwise.
6.6 The order confirmation will be sent by email and will include or confirm the order number, Product details, quantity, total price, payment status, delivery address, estimated delivery timeframe and withdrawal information where applicable. The Legal Documents are made available through the Website. The Privacy Policy, App EULA and Legal Disclaimer for the GlucoSensor™ Q App are also made available through the App where relevant. Where required by applicable law, Maralvion will provide the applicable contractual information, withdrawal information and model withdrawal form on a durable medium or by another legally valid method.
6.7 All orders are subject to Product availability, payment authorisation, delivery availability, legal availability, fraud checks, medical device related checks and any applicable quantity limits.
6.8 Maralvion may refuse, suspend or cancel an order before dispatch where there are reasonable grounds to do so, including payment failure, suspected fraud, incorrect pricing, Product unavailability, legal restrictions, delivery impossibility, sanctions concerns, safety concerns, misuse of customer accounts, abuse of return or replacement procedures or suspected unauthorised resale.
6.9 If a Product becomes unavailable after the Customer has placed an order, Maralvion will inform the Customer and offer a lawful solution, such as delayed delivery, partial delivery, cancellation, refund or another appropriate remedy.
6.10 Maralvion may apply quantity limits, order frequency limits, country restrictions or other reasonable restrictions to protect Product availability, prevent unauthorised resale, reduce fraud, comply with medical device obligations or protect Customers and Users.
ARTICLE 7. PRICES, TAXES AND PAYMENT
7.1 Product prices are displayed before checkout. Prices shown to Consumers include applicable VAT, unless expressly stated otherwise.
7.2 Prices shown to Business Customers may be shown exclusive of VAT where this is expressly indicated and legally permitted. Business Customers are responsible for providing complete and accurate invoicing information, including any valid VAT identification number required for tax, reverse charge, invoicing or reporting purposes.
7.3 Shipping costs, delivery charges and any other mandatory costs payable by the Customer will be shown before the Customer confirms the order.
7.4 Payment must be made using one of the payment methods offered during checkout. Available payment methods may differ by country, currency, Customer type, order value, payment provider availability or risk assessment.
7.5 Maralvion may use third party payment service providers to process payments securely. Such payment service providers may apply their own technical requirements, payment authentication steps, payment rules and privacy information.
7.6 An order will not be processed for dispatch until payment has been successfully received or authorised, unless Maralvion expressly agrees otherwise.
7.7 If a payment is refused, reversed, charged back, cancelled, unauthorised or otherwise not successfully completed, Maralvion may suspend delivery, cancel the order, recover unpaid amounts, restrict future orders or take other lawful steps to protect its rights.
7.8 Maralvion may change prices for future orders. Price changes do not affect orders already confirmed, unless the price shown was clearly incorrect and the Customer could reasonably have recognised the error.
7.9 Discounts, promotional codes, free shipping offers, introductory offers and other promotions may be subject to specific conditions, expiry dates, country limitations, order limits, Product exclusions or Customer eligibility requirements. Promotions cannot be exchanged for cash, unless mandatory law provides otherwise.
7.10 Where required by law or requested by the Customer, Maralvion may provide an invoice or order receipt. The Customer is responsible for ensuring that invoice details are correct when placing the order.
ARTICLE 8. DELIVERY, SHIPPING AND RISK TRANSFER
8.1 Maralvion delivers Products only to countries and addresses where delivery is offered, legally permitted and practically available.
8.2 Delivery is carried out by postal operators, courier services, fulfilment partners or logistics service providers selected by Maralvion.
8.3 Maralvion aims to deliver orders within the estimated delivery timeframe shown during checkout, in the order confirmation or in the dispatch communication. Delivery timeframes are indicative, unless expressly confirmed as binding.
8.4 Where technically available, the Customer may receive a dispatch confirmation by email. The dispatch confirmation may include tracking information.
8.5 If Maralvion cannot deliver within the expected timeframe, Maralvion will inform the Customer and provide an updated estimated delivery timeframe where reasonably possible.
8.6 If delivery to a Consumer has not taken place within 30 days after conclusion of the contract, or within another period expressly agreed with the Consumer, the Consumer may require delivery within an additional period appropriate to the circumstances. If Maralvion does not deliver within that additional period, or where delivery within the agreed period was essential and Maralvion was aware of this, the Consumer may cancel the contract and receive a refund for the undelivered Products in accordance with applicable consumer law.
8.7 The Customer is responsible for ensuring that the delivery address is complete, accurate and accessible. Maralvion is not responsible for failed or delayed delivery caused by incorrect, incomplete or outdated delivery information provided by the Customer, except where mandatory law provides otherwise.
8.8 If the Customer selects delivery to a collection point, parcel locker or similar delivery location, the Customer is responsible for collecting the parcel within the period stated by the carrier. Failure to collect the parcel may result in return shipment, delay, additional shipping costs or cancellation, subject to applicable law.
8.9 For Consumers, the risk of loss or damage passes to the Consumer when the Consumer, or a third party designated by the Consumer other than the carrier, has acquired physical possession of the Product. If the Consumer chooses a carrier that was not offered by Maralvion, risk may pass to the Consumer when the Product is handed over to that carrier, where permitted by law.
8.10 For Business Customers, the risk of loss or damage passes when the Product is handed over to the carrier or logistics provider for delivery, unless expressly agreed otherwise in writing or mandatory law provides otherwise.
ARTICLE 9. RECEIPT, NON DELIVERY AND TRANSPORT ISSUES
9.1 Upon receipt, the Customer should check whether the package appears externally intact and whether the delivered items correspond to the order confirmation.
9.2 Visible transport damage, missing items, incorrect delivery or an incomplete delivery should be reported to Customer Support as soon as reasonably possible, preferably within 48 hours after delivery.
9.3 Reports under Article 9.2 should include the order number, a clear description of the issue and, where possible, photographs of the external packaging, shipping label, Product packaging and any visible damage or discrepancy.
9.4 The preferred 48 hour reporting period is intended to allow prompt investigation with the carrier. It does not limit mandatory consumer rights, statutory conformity rights, Product safety rights or any other rights that cannot be limited under applicable law.
9.5 If an order appears to be lost, delayed or not delivered within the expected timeframe, the Customer should contact Customer Support. Maralvion may open an investigation with the carrier and may request reasonable cooperation from the Customer.
9.6 If non delivery, transport loss, incorrect delivery, incomplete delivery or transport damage is confirmed, Maralvion will provide an appropriate remedy in accordance with applicable law. This may include replacement delivery, completion of the order, refund or another lawful solution.
9.7 If a Product appears damaged, visibly compromised, incorrectly supplied, incomplete or otherwise visibly non conforming, the Customer should contact Customer Support before using or disposing of the Product, unless immediate disposal is necessary for safety, hygiene, medical or legal reasons.
9.8 Where a delivery issue is reported, the Customer must preserve available evidence where reasonably possible, including the Product, Product packaging, shipping label, photographs, lot information, Sensor Serial Number and other relevant materials. More detailed evidence and retention obligations for complaints, replacement requests, safety assessments and regulatory follow up are set out in Article 16.
9.9 Where a delivery issue may indicate a Product safety issue, Product defect or medical device complaint, Maralvion may handle the matter as a product complaint and may assess, document or escalate the matter in accordance with these Terms, the Privacy Policy and applicable medical device law.
ARTICLE 10. CHANGES TO ORDERS, DELIVERY DETAILS AND CANCELLATION BEFORE DISPATCH
10.1 The Customer may request a change to an order, delivery address, billing address, Product quantity or delivery method by contacting Customer Support as soon as possible after placing the order.
10.2 Maralvion may accept a change request only if the order has not yet been processed for fulfilment or dispatch and the requested change is technically, legally and logistically possible.
10.3 Once an order has been processed for fulfilment or handed over to the carrier, Maralvion may no longer be able to change the delivery address, delivery method, Product quantity or order content.
10.4 The Customer may request cancellation of an order before dispatch by contacting Customer Support as soon as possible.
10.5 Cancellation before dispatch is possible only if the order has not yet been processed for fulfilment or handed over to the carrier.
10.6 If Maralvion accepts a cancellation request before dispatch, Maralvion will cancel the order and refund the amount paid using the original payment method, unless another method is agreed and no additional cost is imposed on the Consumer.
10.7 If the order has already been dispatched, cancellation, withdrawal, returns and refunds are governed by the right of withdrawal, the Returns and Refund Policy, these Terms and applicable consumer law.
10.8 Maralvion may cancel, refuse or suspend an order before dispatch in accordance with Article 6.8 and applicable law.
ARTICLE 11. SUBSCRIPTIONS AND RECURRING DELIVERIES
11.1 This Article applies only where Maralvion offers subscription plans, recurring orders, automatic renewal plans or scheduled deliveries for GlucoSensor™ Q.
11.2 Before the Customer enters into a subscription or recurring delivery plan, Maralvion will provide the applicable Product quantity, delivery frequency, billing frequency, price, shipping costs, minimum commitment period where applicable, renewal conditions, pause options where available and cancellation method.
11.3 If a subscription renews automatically, this will be clearly stated before checkout. The Customer authorises Maralvion or its payment service provider to charge the applicable recurring amount at the stated billing interval until the subscription is paused, cancelled or otherwise terminated in accordance with the applicable terms.
11.4 The Customer is responsible for keeping Account details, delivery address, payment method, email address and other subscription information complete and up to date.
11.5 The Customer may request changes to a subscription, including delivery address, payment method, delivery frequency or Product quantity, through the Account environment on the Website or by contacting Customer Support.
11.6 Where this functionality is made available, the Customer may temporarily pause a subscription through the Account environment on the Website and reactivate it later. A pause or reactivation applies only to future deliveries and future billing periods if submitted and confirmed before the relevant order has been processed for fulfilment or dispatch.
11.7 Subscription changes apply only to future deliveries if submitted before the relevant order has been processed for fulfilment or dispatch.
11.8 The Customer may cancel a subscription in accordance with the cancellation method stated at the time of subscription purchase, through the Account environment on the Website or through Customer Support. Where mandatory law requires an online cancellation function or another specific cancellation method, Maralvion will make such method available.
11.9 Cancellation or pausing of a subscription does not affect orders already processed for fulfilment or dispatch, unless Maralvion confirms otherwise or mandatory law provides otherwise.
11.10 Each subscription delivery may have its own withdrawal period where required by applicable consumer law. Refunds, returns and withdrawal rights for subscription deliveries are governed by these Terms, the Returns and Refund Policy and applicable consumer law.
11.11 Maralvion may change the price, delivery frequency, Product configuration or other subscription conditions for future subscription periods where there is a valid reason and where legally permitted. Maralvion will provide notice where required by applicable law. Such changes do not affect subscription deliveries already confirmed, unless mandatory law provides otherwise.
11.12 A subscription plan does not guarantee uninterrupted Product availability and does not change the IFU, intended use, maximum wear period, storage requirements, safety information, statutory rights, return conditions or replacement conditions applicable to each Product.
ARTICLE 12. RIGHT OF WITHDRAWAL AND RETURNS
12.1 Consumers have the statutory right to withdraw from a distance purchase within 14 days after receiving the Product, without giving a reason, subject to the conditions and exceptions set out in these Terms, the Returns and Refund Policy and applicable consumer law.
12.2 For physical Products, the withdrawal period starts on the day on which the Consumer, or a third party designated by the Consumer other than the carrier, receives physical possession of the Product. Where an order is delivered in several separate shipments, the withdrawal period starts on the day on which the Consumer, or a third party designated by the Consumer other than the carrier, receives physical possession of the last Product in that order.
12.3 To exercise the right of withdrawal, the Consumer must inform Maralvion before the withdrawal period expires by sending a clear withdrawal statement to support@glucosensor.com. The Consumer may use a model withdrawal form where Maralvion provides one, but use of such form is not mandatory unless mandatory law provides otherwise. Where Maralvion is required by mandatory law to make an electronic withdrawal function available through the Website or another online interface, the Consumer may also use that function.
12.4 The Consumer may open the outer shipping box and inspect the Product in a way that is reasonably necessary to establish the nature, characteristics and functioning of the Product. Because GlucoSensor™ Q is a personal use medical device supplied in sealed Product packaging, the sealed Product packaging, hygiene seal, sterility protection, tamper protection, Product labelling, IFU, Quick Guide, lot information, Sensor Serial Number and other regulatory information must remain intact if the Consumer wishes to return the Product under the right of withdrawal.
12.5 Opening the outer shipping box does not by itself remove the right of withdrawal, provided that the sealed Product packaging, hygiene seal, sterility protection, tamper protection, Product labelling, IFU, Quick Guide, lot information, Sensor Serial Number and other regulatory information remain intact.
12.6 For reasons of health protection, hygiene, sterility and Product safety, the right of withdrawal does not apply once the sealed Product packaging, hygiene seal, sterility protection or tamper protection has been opened or broken after delivery, where the Product is not suitable for return for those reasons.
12.7 Opened, unsealed, used, activated, applied, contaminated, damaged, incomplete or otherwise compromised Sensors cannot be returned under the right of withdrawal and cannot be resold, reused, resterilised or supplied to another user, unless mandatory law provides otherwise. This does not affect the Consumer’s statutory rights where the Product is defective or non conforming.
12.8 Products returned under the right of withdrawal must be complete and must include all items supplied in the relevant Product packaging, including the Sensor supplied in its applicator, the IFU, the Quick Guide, the adhesive patch and the related Product packaging and labelling, unless mandatory law provides otherwise.
12.9 The Consumer must follow the return procedure stated in the Returns and Refund Policy. Products must be returned only to the return address stated in the Returns and Refund Policy or otherwise confirmed by Customer Support.
12.10 The Consumer is responsible for the direct cost of returning Products under the right of withdrawal, unless Maralvion has expressly agreed otherwise or mandatory law requires a different result.
12.11 The Consumer must return the Product without undue delay and no later than 14 days after informing Maralvion of the decision to withdraw, unless mandatory law provides otherwise.
12.12 Maralvion will reimburse eligible payments without undue delay and no later than the period required by applicable consumer law. Maralvion may withhold reimbursement until it has received the returned Product or until the Consumer has supplied evidence of having sent back the Product, whichever occurs first, unless mandatory law requires otherwise.
12.13 Refunds will be made using the same payment method used for the original transaction, unless the Consumer expressly agrees to another method and no additional cost is imposed on the Consumer.
12.14 The Customer bears the return shipping costs, return packaging costs, insurance for return shipment and any optional return delivery services selected by the Customer, unless Maralvion has expressly agreed otherwise or mandatory law requires a different result. Where mandatory consumer law requires reimbursement of standard outbound delivery costs after valid withdrawal from the entire order, Maralvion will reimburse only the least expensive standard delivery method offered by Maralvion for that order. Additional outbound delivery costs resulting from the Customer’s choice of a more expensive delivery method are not reimbursed, unless mandatory law provides otherwise.
12.15 The Customer is responsible for ensuring that returned Products are securely packaged and shipped using a suitable shipping method. The risk of loss or damage during return shipment remains with the Customer until the returned Product is received by Maralvion or its designated return handler, unless mandatory law provides otherwise.
12.16 Business Customers do not have a statutory consumer right of withdrawal. Returns by Business Customers are accepted only where expressly agreed by Maralvion, required by mandatory law or required under an applicable written agreement.
ARTICLE 13. RETURNED GOODS INSPECTION
13.1 All returned Products are subject to inspection upon receipt.
13.2 Returned Products may be inspected for packaging condition, seal integrity, completeness, damage, contamination, signs of opening, signs of use, expiry, lot information, Sensor Serial Number, matching order details and compliance with the Returns and Refund Policy.
13.3 Where the returned Product is complete, unused and returned with the sealed Product packaging, hygiene seal, sterility protection, tamper protection, Product labelling, IFU, Quick Guide, lot information, Sensor Serial Number and other regulatory information intact, Maralvion will process the return and refund in accordance with Article 12, the Returns and Refund Policy and applicable consumer law.
13.4 Maralvion will not refuse a withdrawal return or reduce a refund solely because the Consumer opened the outer shipping box or inspected the Product in a way reasonably necessary to establish the nature, characteristics and functioning of the Product, provided that the sealed Product packaging, hygiene seal, sterility protection and tamper protection remain intact.
13.5 Maralvion may refuse a withdrawal return where the Product is not suitable for return because the sealed Product packaging, hygiene seal, sterility protection or tamper protection has been opened or broken after delivery for a Product that cannot be returned for reasons of health protection, hygiene, sterility or Product safety.
13.6 Where mandatory consumer law allows the right of withdrawal to remain available but the Product has been handled beyond what is necessary to establish its nature, characteristics and functioning, Maralvion may reduce the refund to reflect the diminished value of the Product to the extent permitted by applicable consumer law.
13.7 Because GlucoSensor™ Q Sensors are sealed, personal use, single use medical device components, Article 13.6 will generally not apply to a Sensor once the sealed Product packaging, hygiene seal, sterility protection or tamper protection has been opened or broken and the Sensor is no longer suitable for return for health protection, hygiene, sterility or Product safety reasons.
13.8 Products that cannot be returned for health protection, hygiene, sterility or Product safety reasons may be rejected, quarantined, destroyed or otherwise handled in accordance with applicable procedures.
13.9 The outcome of a return inspection does not affect the Customer’s right to submit a statutory conformity claim, Product safety complaint or Sensor replacement request where applicable.
13.10 Where the Customer claims that a Product was defective, damaged, incorrect or non conforming at delivery, Maralvion may request reasonable evidence, including photographs, packaging information, lot number, Sensor Serial Number, order number, App screenshots, App logs or return of the Product for inspection.
ARTICLE 14. STATUTORY CONFORMITY, WARRANTIES AND PRODUCT DEFECTS
14.1 Nothing in these Terms limits, excludes or restricts statutory consumer rights that cannot be limited, excluded or restricted under applicable EU or national consumer law.
14.2 Consumers benefit from the statutory legal guarantee of conformity for goods for the period required by applicable EU and national consumer law. This statutory guarantee means that the Product must conform to the contract, Product description, applicable legal requirements and reasonable expectations based on the nature, purpose, packaging, labelling, shelf life, intended wear period and IFU of the Product.
14.3 Where GlucoSensor™ Q, the App or related digital functionality qualifies as a good with digital elements, digital content or a digital service under applicable Digital Content Laws, the Customer and User retain any mandatory rights and remedies that apply under those laws. App access, App functionality, App updates, digital content, digital services and App related digital conformity are primarily governed by the App EULA, without limiting mandatory statutory rights relating to goods with digital elements where applicable.
14.4 The statutory legal guarantee does not create a commercial two year performance warranty, does not extend the Product’s expiry date, does not extend the Sensor’s maximum intended wear period and does not change the single use nature of the Sensor.
14.5 Each Sensor is a single use medical device component intended for a maximum wear period of 14 days, subject to correct storage, correct handling, correct placement, successful activation, App operation, mobile device compatibility, connectivity, environmental conditions, Product expiry and compliance with the IFU.
14.6 The Product must not be used after its expiry date. The Customer and User must check the Product label, packaging, IFU, Quick Guide and App instructions before use.
14.7 The Product must be stored and handled in accordance with the storage and transport conditions stated on the Product packaging, Product labelling and IFU. Incorrect storage, exposure to unsuitable environmental conditions or use after expiry may affect Product safety and performance.
14.8 A Product defect may include a manufacturing defect, material defect, packaging defect, sterility concern, confirmed Product malfunction, App recognised Sensor failure or another issue not caused by misuse, incorrect handling, incorrect storage, failure to follow the IFU or use outside the Product’s intended purpose.
14.9 Warranty, conformity and replacement assessment may require the Customer or User to provide proof of purchase, order number, lot number, Sensor Serial Number, photographs, App screenshots, App logs, Sensor session details, a description of the issue and other information reasonably necessary to assess the claim.
14.10 Where a Product is confirmed to be defective or non conforming, Maralvion will provide a remedy in accordance with applicable law. Depending on the circumstances, this may include replacement, refund, price reduction or another legally required remedy.
14.11 Where repair is not appropriate because of the nature of the Product, including where the Product is a sealed, sterile, single use or disposable medical device component, Maralvion may provide another remedy required or permitted by applicable law.
14.12 Warranty, conformity or replacement assessment may be rejected where the issue results from misuse, incorrect placement, use outside approved placement sites, failure to prepare the skin correctly, failure to follow the IFU, use beyond the indicated wear period, use after expiry, incorrect storage, packaging damage after delivery, external impact, attempted repair, modification, unauthorised software, unsupported mobile device settings, water exposure outside the IFU, electromagnetic interference or other circumstances outside the Product’s intended use.
14.13 Commercial goodwill replacements, where offered, do not create an entitlement to future replacements and do not limit Maralvion’s ability to assess future claims individually.
14.14 Because GlucoSensor™ Q uses an integrated sensor design and does not include a separate reusable transmitter, no separate reusable transmitter warranty, return right or replacement right applies.
ARTICLE 15. SENSOR REPLACEMENT REQUESTS
15.1 Sensor replacement requests are governed by the Sensor Replacement Policy. This Article summarises the main principles and does not replace the full Sensor Replacement Policy.
15.2 A Sensor may qualify for replacement where Maralvion determines, after reasonable review, that the Sensor failed during the intended wear period due to a Product defect or confirmed malfunction not caused by user handling, incorrect placement, incorrect skin preparation, external impact, environmental exposure, connectivity settings, mobile device settings, use outside the IFU or another excluded cause.
15.3 A Sensor replacement request must first be submitted to Customer Support at support@glucosensor.com. After the initial request has been received, Maralvion may provide the Customer or User with a Sensor Replacement Form to complete. The Sensor Replacement Form may request the order number, Sensor Serial Number, lot number, date and time of placement, date and time of failure, App screenshots, photographs of the Sensor and placement site, a description of the issue, mobile device model, operating system, App version and any other relevant information reasonably required for assessment.
15.4 Maralvion may review App logs, technical data, Sensor session data and support information to assess a replacement request, in accordance with the Privacy Policy and applicable data protection law.
15.5 A Sensor will generally not qualify for replacement where the issue is likely to result from incorrect use, incorrect storage, incorrect placement, insufficient skin preparation, premature removal, detachment caused by external factors, physical impact, friction, pressure, unsuitable skin condition, water exposure outside the IFU, use after expiry, damaged packaging after delivery, unauthorised software or other circumstances outside correct use.
15.6 Replacement eligibility is assessed case by case. A replacement decision does not constitute an admission of liability, does not create an entitlement to future replacements and does not extend statutory rights beyond what is required by law.
15.7 Where a replacement request may indicate a Product safety issue, Product defect, adverse event, cybersecurity issue or Serious Incident, Maralvion may handle the matter as a product complaint and may assess, document or escalate the matter in accordance with these Terms, the Privacy Policy and applicable medical device law.
ARTICLE 16. PRODUCT COMPLAINTS AND SAFETY RELATED REPORTING
16.1 Complaints about orders, delivery, damaged Products, incorrect Products, missing items, returns, refunds, Sensor performance, technical issues, App issues, Product quality or Product safety may be submitted to Customer Support at support@glucosensor.com.
16.2 A complaint should include the Customer’s name, order number, Product details, lot number, Sensor Serial Number where applicable, a description of the issue, photographs where relevant, App screenshots where relevant, date and time of occurrence, Sensor placement date, mobile device details and any other information reasonably required for investigation.
16.3 Complaints should be submitted within a reasonable time after the Customer or User discovers the issue. Any preferred reporting timelines stated in these Terms or related policies are intended to support prompt investigation and do not limit mandatory legal rights.
16.4 Where applicable consumer law requires Maralvion to respond to a Consumer complaint within a specific period, including a 14 day period for certain Consumer complaints under Polish consumer law, Maralvion will respond within that period on a durable medium or by another legally valid method. Any legal consequence of not responding within a mandatory period is governed by applicable law.
16.5 Maralvion may classify a complaint as a delivery complaint, customer service complaint, statutory conformity claim, warranty claim, replacement request, Product complaint, technical complaint, medical device complaint, cybersecurity concern or potential Serious Incident.
16.6 Where a complaint may indicate a Product safety issue, Product defect, adverse event, cybersecurity issue, vigilance event or Serious Incident, Maralvion may forward relevant information to Dreisam, Firsteck Bio S.r.l., competent authorities, notified bodies, insurers, legal advisers, Authorised Service Providers or other relevant parties where necessary for Product safety, regulatory compliance, legal claims, support handling or statutory obligations.
16.7 If a Customer or User believes that a Product issue may have caused or contributed to serious harm or a serious deterioration in health, the matter should be reported promptly to Maralvion at support@glucosensor.com, so that it can be assessed and handled where required under applicable medical device law.
16.8 Nothing in these Terms is intended to prevent any reporting that is required or expressly permitted under applicable medical device law. Maralvion may assess, document and escalate Product safety information to the Manufacturer, the Authorised Representative, competent authorities or other relevant parties where required or permitted by applicable law.
16.9 The Customer and User must provide reasonable cooperation in Product complaint, vigilance, conformity, warranty, replacement, recall, field safety corrective action or Serious Incident investigations, including providing relevant Product information, photographs, App data, returned Products, descriptions of use and other information reasonably required for investigation.
16.10 The Customer and User must retain the Product, Product packaging, shipping label, IFU, Quick Guide, adhesive patch, lot information, Sensor Serial Number, App screenshots, photographs, support communications and other relevant evidence where reasonably necessary for complaint handling, replacement assessment, safety assessment, conformity assessment or regulatory follow up. The Customer and User must not dispose of relevant materials before Maralvion has had a reasonable opportunity to review the issue, unless immediate disposal is necessary for safety, hygiene, medical or legal reasons. Where disposal is necessary, the Customer or User should preserve reasonable alternative evidence, including photographs, lot information, Sensor Serial Number and a description of the circumstances.
16.11 Maralvion may keep records of order numbers, lot numbers, Sensor Serial Numbers, shipment information, complaint information, replacement information, return information and other relevant information as required or permitted by applicable medical device law, consumer law, product safety law, tax law and data protection law.
16.12 If a field safety notice, recall, Product correction, App safety update or other safety related measure is required, Maralvion may contact Customers and Users using the contact details available to Maralvion. The Customer and User must follow all safety instructions, recall instructions and field safety instructions provided by Maralvion, Dreisam, Firsteck Bio S.r.l. or competent authorities.
16.13 The Customer Support limitations set out in Article 3.8 also apply to all complaints, support requests, replacement requests and safety related reports submitted under this Article 16.
ARTICLE 17. LIABILITY
17.1 Nothing in these Terms excludes, restricts or limits liability for death or personal injury caused by negligence, fraud, intentional misconduct, gross negligence, statutory product liability, mandatory consumer rights, mandatory medical device obligations, data protection rights, Digital Content Laws or any other liability, right, remedy, obligation or protection that cannot be excluded, restricted or limited under applicable law.
17.2 If the Customer is a Consumer, the liability provisions in these Terms apply only to the extent permitted by applicable mandatory consumer protection law. Nothing in these Terms affects the Consumer’s statutory rights in relation to non conforming goods, defective products, Product safety, medical device safety, personal injury, withdrawal rights, refunds, digital content rights, goods with digital elements or any other mandatory legal protection.
17.3 Maralvion remains responsible for obligations assigned to it as seller, EU importer, App operator, order fulfilment party and customer facing economic operator under applicable law, including obligations relating to Product availability, order fulfilment, delivery, statutory conformity, importer related checks, complaint handling, customer support and cooperation with the Manufacturer, the Authorised Representative and competent authorities where required.
17.4 Dreisam remains responsible as legal Manufacturer for the legal obligations assigned to the Manufacturer under applicable medical device law and product liability law, including obligations relating to System design, manufacture, conformity assessment, Sensor technology, the Manufacturer SDK, manufacturer supplied or manufacturer authorised software components, clinical performance, CE marking, technical documentation, post market surveillance and vigilance.
17.5 Subject to Articles 17.1 to 17.4, and to the fullest extent permitted by applicable law, Maralvion is not liable for damage, loss, inaccurate readings, missed alerts, failed Sensor sessions, data gaps, support delays or other consequences to the extent caused by use outside the IFU, Product labelling, Quick Guide, App instructions, safety notices, these Terms, the App EULA, the Legal Disclaimer for the GlucoSensor™ Q App or applicable medical guidance.
17.6 Subject to Articles 17.1 to 17.4, and to the fullest extent permitted by applicable law, Maralvion is not liable for damage, loss or other consequences to the extent caused by incorrect storage, incorrect handling, incorrect placement, use after expiry, physical damage after delivery, external impact, unauthorised software, unauthorised integrations, unsupported devices, disabled alerts, missed notifications, interrupted connectivity, incorrect App settings, incorrect measurement units, water exposure outside the IFU, electromagnetic interference or other circumstances outside Maralvion’s reasonable control.
17.7 Subject to Articles 17.1 to 17.4, and to the fullest extent permitted by applicable law, Maralvion is not liable for inaccuracies, delays, interruptions, data gaps, output limitations, alert limitations, report limitations or other System performance issues to the extent attributable to the Sensor, the Manufacturer SDK, manufacturer supplied or manufacturer authorised software components, manufacturer controlled functionality, or other matters for which the Manufacturer remains responsible within the Manufacturer’s role.
17.8 To the fullest extent permitted by applicable law, Maralvion is not liable for indirect, incidental, special or consequential damages, including loss of profits, loss of revenue, loss of business, loss of goodwill, reputational harm, loss of data, missed opportunities, business interruption or other indirect commercial losses.
17.9 If the Customer is a Business Customer, Maralvion’s liability for direct damages arising from or related to an order, delivery, return, refund, replacement request, support matter or Product transaction is limited, to the fullest extent permitted by law, to the amount paid by the Business Customer for the specific Product giving rise to the claim.
17.10 Authorised Service Providers engaged by Maralvion are not contracting parties to the sales contract and do not act as seller, EU importer, legal manufacturer or authorised representative, unless expressly identified as such in official documentation or where mandatory law provides otherwise. This does not exclude liability for their own acts or omissions where such liability cannot be excluded under applicable law.
17.11 The Customer and User remain responsible for reading and following the IFU, Product labelling, Quick Guide, App instructions, safety warnings, contraindications, precautions, applicable Legal Documents and applicable medical guidance.
ARTICLE 18. WEBSITE, APP AND THIRD PARTY OPERATIONAL SERVICES
18.1 Access to the Website, webshop, Account environment, payment services, authentication services, hosting services, logistics services, email services, analytics services, customer support systems and other operational services may depend on third party providers.
18.2 Maralvion may use Authorised Service Providers for hosting, authentication, payment processing, fulfilment, logistics, customer support, technical support, marketing, content, analytics, accounting, legal, regulatory, compliance and administrative services.
18.3 Maralvion aims to maintain reliable Website, webshop, order and support services, but does not guarantee uninterrupted, error free or continuous availability of the Website, webshop, payment systems, logistics systems, Account environment or support systems.
18.4 Temporary interruptions may occur due to maintenance, updates, cyber incidents, security measures, hosting issues, payment provider issues, authentication provider issues, network issues, logistics issues, regulatory measures, force majeure events or other technical or operational circumstances.
18.5 The use of the App is governed by the App EULA and the Legal Disclaimer for the GlucoSensor™ Q App. Any statutory digital content, digital service or goods with digital elements rights relating to the App, related digital functionality or App updates are governed by the App EULA, Digital Content Laws and applicable mandatory consumer protection laws, without limiting mandatory rights relating to the sale of Products under these Terms.
18.6 If the Customer or User interacts with third party platforms, including payment providers, logistics providers, authentication providers, analytics providers, Apple App Store, Google Play or linked websites, such use may be subject to the third party’s own terms and privacy notices.
18.7 Maralvion is not responsible for third party platforms, third party services, third party terms, third party privacy practices, third party availability or third party acts or omissions, except to the extent Maralvion is legally responsible under mandatory applicable law.
ARTICLE 19. PERSONAL DATA
19.1 Maralvion processes Personal Data in connection with orders, payments, deliveries, returns, refunds, subscriptions, customer support, product complaints, replacement requests, safety notices, legal compliance and related GlucoSensor™ Q services in accordance with the Privacy Policy and applicable data protection law.
19.2 The Privacy Policy governs the processing of Personal Data, Health Data, CGM Data, Device Data, Sensor Data, support information, complaint information, replacement information, regulatory information and related data protection matters.
19.3 Where a support request, complaint, replacement request, warranty assessment, Product safety matter or Serious Incident report involves Health Data, CGM Data, App screenshots, glucose readings, glucose reports or other sensitive information, such information is handled in accordance with the Privacy Policy and applicable data protection law.
19.4 These Terms do not replace, amend or limit the Privacy Policy. In the event of any inconsistency concerning privacy, data protection, data subject rights, legal bases, retention periods, recipients, international transfers or the processing of Personal Data, the Privacy Policy prevails.
ARTICLE 20. INTELLECTUAL PROPERTY
20.1 GlucoSensor™ Q, the GlucoSensor brand, the Website, domain names, Product content, documentation, packaging artwork, graphics, photographs, videos, tutorials, Product descriptions, trade names, trademarks, logos, designs, commercial documentation, App related commercial materials and related brand assets are protected by intellectual property rights.
20.2 All intellectual property rights in the materials referred to in Article 20.1 are owned by or licensed to Maralvion, or are owned by other respective rights holders. Maralvion is authorised to use the GlucoSensor and GlucoSensor™ Q brand and related materials for the commercialisation, sale, distribution and support of GlucoSensor™ Q.
20.3 Dreisam retains all intellectual property rights relating to the medical device technology, System technology, Sensor technology, applicator technology, the Manufacturer SDK, manufacturer supplied or manufacturer authorised software components, firmware, technical documentation, clinical performance data, regulatory documentation, certified System functionality and manufacturer know how.
20.4 Maralvion and its licensors retain all intellectual property rights relating to the GlucoSensor brand, Website, webshop, Account environment, App user interface, local market configuration, support flows, language versions, content, visual presentation, commercial materials, non measurement related App components and related services, except where such rights belong to Dreisam, App Stores, Authorised Service Providers or other relevant third parties.
20.5 The Customer and User receive no ownership rights in any intellectual property. The Customer and User may use Product materials only for personal, lawful and intended use of GlucoSensor™ Q.
20.6 The Customer and User must not copy, reproduce, modify, translate, distribute, publish, scrape, commercially exploit, relabel, repackage, reverse engineer, decompile, disassemble or create derivative works from any GlucoSensor™ Q Product, Sensor, App, Manufacturer SDK, Website content, packaging, documentation, App content, brand asset, technical material or regulatory material, except where expressly permitted by mandatory law.
20.7 If the Customer or User submits feedback, reviews, suggestions, testimonials, comments, photographs or other content to Maralvion or Customer Support, the Customer or User grants Maralvion and its Authorised Service Providers a non exclusive, worldwide, royalty free licence to use such content for customer support, product improvement, internal analysis, legal compliance, marketing or service improvement, subject to the Privacy Policy and applicable law. Where applicable law requires additional consent for a specific use, Maralvion will rely on such consent before using the content for that specific purpose.
20.8 The Customer and User must not submit content that is unlawful, misleading, defamatory, infringing, offensive, confidential, privacy infringing, medically unsafe or otherwise inappropriate. Maralvion may remove, refuse or stop using submitted content where reasonably necessary.
20.9 Unauthorised use of the GlucoSensor or GlucoSensor™ Q brand, Website, content, packaging, documentation, App materials, technical materials or other protected assets may result in legal action.
ARTICLE 21. FORCE MAJEURE
21.1 Maralvion is not liable for delay or failure to perform obligations caused by events beyond its reasonable control, including natural disasters, pandemics, epidemics, war, terrorism, civil unrest, strikes, labour disputes, cyberattacks, power outages, network failures, supplier disruptions, manufacturing delays, quality holds, customs issues, transport disruptions, governmental measures, regulatory actions, sanctions, embargoes, Product safety holds, recalls, field safety corrective actions or other events outside its reasonable control.
21.2 During a force majeure event, Maralvion’s affected obligations may be suspended for the duration of the event.
21.3 If a force majeure event prevents delivery for more than 60 days, either Maralvion or the Customer may cancel the affected order. Maralvion will refund amounts paid for undelivered Products, subject to applicable law.
21.4 Nothing in this Article limits mandatory consumer rights, including rights relating to non delivery, withdrawal, statutory conformity, digital content rights, goods with digital elements or refunds.
ARTICLE 22. EXPORT RESTRICTIONS AND LEGAL AVAILABILITY
22.1 The Customer must not purchase, export, re export, transfer, resell, redistribute, relabel, repackage or use GlucoSensor™ Q in violation of applicable laws, including medical device laws, export control laws, sanctions laws, customs laws, consumer protection laws, Product safety laws, tax laws and data protection laws.
22.2 Maralvion may refuse, cancel or suspend orders where it reasonably believes that fulfilment would violate applicable law, sanctions, export restrictions, import restrictions, medical device restrictions, payment restrictions, logistics restrictions or other regulatory obligations.
22.3 GlucoSensor™ Q is made available only in countries where Maralvion chooses to offer, deliver and support it. Technical access to the Website, App, App Store listing, online content or support information from another country does not mean that Maralvion offers, supplies, supports or authorises GlucoSensor™ Q in that country.
22.4 Customers and Users outside the countries specifically targeted by Maralvion are responsible for verifying whether possession, use, import, support or continued use of GlucoSensor™ Q is lawful and appropriate in their jurisdiction.
22.5 Maralvion may limit, suspend or discontinue sales, support, delivery or availability in a country where legal, regulatory, commercial, logistics, payment, Product safety or medical device considerations reasonably require this.
ARTICLE 23. CHANGES TO THESE TERMS
23.1 Maralvion may update these Terms where there is a valid reason to do so, including changes in applicable law, medical device requirements, consumer protection rules, Digital Content Laws, Product information, safety requirements, cybersecurity requirements, operational processes, payment methods, delivery arrangements, subscription arrangements, support procedures, service providers or business operations.
23.2 The version of these Terms accepted at the time of order applies to that order, unless a later change is required by mandatory law, Product safety, medical device obligations, a recall, a field safety corrective action, a competent authority instruction or another legal obligation.
23.3 Updated Terms will be published on the Website. Where a change is material and affects Customers or Users in more than a minor way, Maralvion will take reasonable steps to provide notice through the Website, email, Account environment, App notice or another appropriate communication channel.
23.4 Updated Terms apply to future orders from the effective date stated in the updated version, unless mandatory law provides otherwise.
23.5 No change to these Terms will retroactively reduce mandatory rights, remedies or protections that a Consumer already has in relation to a confirmed order.
ARTICLE 24. CUSTOMER COMMUNICATIONS AND NOTICES
24.1 Maralvion may communicate with the Customer or User by email, Website notice, Account notice, App notice, telephone, postal mail or another appropriate communication channel, depending on the nature of the communication.
24.2 The Customer is responsible for ensuring that Account information, email address, delivery address, billing information, payment information and other contact details are complete, accurate and kept up to date.
24.3 Transactional and service communications may include order confirmations, payment confirmations, invoices, shipping updates, delivery updates, subscription information, subscription pause or reactivation information, return updates, refund updates, support communications, complaint communications, replacement communications, Account notices, legal notices and policy updates.
24.4 Product safety communications, recall notices, field safety notices, mandatory Product communications, App safety notices, cybersecurity notices, regulatory communications and other safety related communications are not marketing communications. They may be sent where required or appropriate for Product safety, user safety, legal compliance, regulatory compliance or medical device obligations.
24.5 Marketing communications will be sent only where legally permitted and, where required, only after valid consent. The Customer or User may unsubscribe or withdraw marketing consent at any time.
24.6 Formal notices concerning orders, customer claims, Product related legal matters, consumer law claims or regulatory correspondence concerning GlucoSensor™ Q should be sent to Maralvion at the postal address stated in Article 1.20, unless mandatory law requires another recipient or another procedure.
24.7 Customer Support may also be contacted at support@glucosensor.com for practical assistance. Contacting Customer Support does not replace urgent medical care, emergency assistance or any formal notice procedure required by mandatory law.
ARTICLE 25. FINAL PROVISIONS
25.1 A failure or delay by Maralvion to exercise or enforce any right, remedy or provision under these Terms does not constitute a waiver of that right, remedy or provision.
25.2 Any waiver by Maralvion must be explicit and in writing to be valid. A waiver of one breach or default does not constitute a waiver of any future breach or default.
25.3 The Customer may not assign or transfer rights or obligations under these Terms without Maralvion’s prior written consent, except where mandatory law provides otherwise.
25.4 Maralvion may assign or transfer its rights and obligations to a successor, acquirer, group company or other third party where this is reasonably necessary for business continuity, corporate restructuring, sale of assets, legal compliance, regulatory compliance, fulfilment, support, Product safety or performance of the contract. Any such assignment or transfer will not reduce mandatory consumer rights, mandatory Product safety obligations, mandatory medical device obligations or mandatory data protection rights.
25.5 Maralvion may use Authorised Service Providers for the purposes described in these Terms, the Privacy Policy and the applicable Legal Documents. This does not reduce Maralvion’s obligations toward Consumers where Maralvion remains responsible under mandatory applicable law.
25.6 If any provision of these Terms is found invalid, unlawful or unenforceable, that provision will be interpreted or modified to the minimum extent necessary to make it valid, lawful and enforceable while preserving its intended effect as far as possible.
25.7 If a provision cannot be interpreted or modified to become valid, lawful and enforceable, that provision will be treated as severed to the minimum extent necessary. The remaining provisions will continue to apply.
25.8 Headings are included for readability and do not affect interpretation.
25.9 References to applicable law include that law as amended, replaced or supplemented, where relevant.
ARTICLE 26. GOVERNING LAW AND DISPUTE RESOLUTION
26.1 These Terms and contracts concluded with Maralvion are governed by the laws of Poland, without prejudice to mandatory consumer protection rights that apply in the country where the Consumer has their habitual residence.
26.2 If the Customer is a Consumer residing in the European Union, the Consumer may benefit from mandatory consumer protection provisions of the country where the Consumer has their habitual residence, where such provisions apply by law.
26.3 Consumers may bring proceedings against Maralvion before the competent courts permitted under applicable EU and national consumer law. Maralvion may bring proceedings against a Consumer only before the courts permitted under applicable consumer jurisdiction rules.
26.4 Maralvion aims to resolve questions, complaints and disputes through Customer Support before escalation. Customers are encouraged to contact Customer Support first so that Maralvion can investigate and propose a suitable solution.
26.5 Where an applicable national alternative dispute resolution body is available and competent, Consumers may have the option to submit a dispute to such body. Maralvion will provide information on applicable dispute resolution options where legally required.
26.6 These Terms do not impose mandatory arbitration on Consumers.
26.7 If the Customer is a Business Customer, disputes arising from or relating to these Terms, an order, delivery, return, refund, replacement request, support matter or Product transaction may be submitted to the competent court for Maralvion’s registered office in Poland, unless Maralvion and the Business Customer have expressly agreed otherwise in writing.
26.8 Nothing in this Article prevents a Customer or User from exercising mandatory rights before a competent court, consumer authority, data protection authority, medical device authority or other body where the Customer or User has the right to do so under mandatory applicable law.
ARTICLE 27. LANGUAGE
27.1 These Terms have been drafted in English.
27.2 Maralvion may make translations or local-language versions of these Terms available through the Website, Website functionality, checkout flow, Account environment, customer support, translation functionality or other communication channels for user convenience, market access, customer information or compliance support.
27.3 To the extent permitted by mandatory applicable law, the English version is the leading and controlling version for interpretation where there is an ambiguity, discrepancy or inconsistency between the English version and any translated or local-language version of these Terms.
27.4 Translated and local-language versions should be interpreted consistently with the English version as far as legally possible. If a translated or local-language version appears unclear, incomplete or inconsistent, Maralvion may correct, update or clarify that version.
27.5 Articles 27.2 to 27.4 do not exclude or reduce mandatory local consumer protection requirements, medical device language requirements, data protection transparency requirements or national rules governing the language in which contractual, consumer, privacy, product or safety information must be supplied, interpreted or made available.
27.6 Where a linguistic discrepancy concerns safe or correct use, intended purpose, indications, contraindications, warnings, precautions, Product performance, Product labelling, the IFU, App warnings, mandatory regulatory information or safety notices, the applicable manufacturer-approved IFU, Product labelling, mandatory regulatory information and safety notices supplied in the language required by applicable law prevail for that specific matter.
ARTICLE 28. CONTACT INFORMATION
28.1 For customer support, orders, delivery, returns, refunds, subscriptions, subscription pause or reactivation requests, complaints, Product issues and Sensor replacement requests, please contact:
GlucoSensor Customer Support
Email: support@glucosensor.com
Website: www.glucosensor.com/support
28.2 Maralvion can be contacted at the postal address stated in Article 1.20. Customer Support can be contacted by email at support@glucosensor.com.
28.3 Product support requests, technical support requests, complaint submissions, safety reports, Sensor replacement requests and medical device related enquiries should be submitted through the official GlucoSensor support channels made available through the Website or App.
28.4 Privacy related questions, requests concerning Personal Data or Health Data and the exercise of data protection rights should be submitted in accordance with the Privacy Policy or by contacting support@glucosensor.com.
28.5 Return shipments must be sent only to the return address stated in the Returns and Refund Policy or otherwise confirmed by Customer Support. Products must not be returned to the registered office, Manufacturer address or Authorised Representative address unless Maralvion expressly instructs the Customer to do so.
28.6 The postal addresses stated in these Terms, the Legal Documents, Product packaging or Product labelling may not be open to the public for visits, returns or in person enquiries unless expressly stated otherwise.
28.7 For urgent medical questions, serious symptoms, suspected hypoglycaemia, suspected hyperglycaemia or medical emergencies, the User must contact a qualified healthcare professional or emergency medical services. Customer Support is not an emergency medical service.