Sensor Replacement Policy

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

IMPORTANT REPLACEMENT SUMMARY

S.1 GlucoSensor™ Q Sensors are single-use disposable medical device components of the GlucoSensor™ Q Continuous Glucose Monitoring System. Each Sensor is intended for one Sensor session and may be worn for up to fourteen (14) days following successful activation, provided it is stored, applied, activated, worn and used in accordance with the Instructions for Use (IFU), product labelling, App instructions and applicable safety information.

S.2 “Up to fourteen (14) days” describes the Maximum Wear Period and the outer limit of intended use. It does not, by itself, create an automatic entitlement to replacement, refund, credit or compensation solely because a Sensor did not remain usable until the end of that period.

S.3 The actual usable duration of an individual Sensor may be affected by correct application and activation, Sensor Placement Site, skin preparation, adhesion, individual skin characteristics, physical activity, sweating, water exposure, environmental conditions, external impact, App functionality, mobile device settings, connectivity and other factors described in the IFU, product labelling or this Policy.

S.4 Maralvion will assess a Replacement Request where a Sensor is reported to have a suspected defect, malfunction, activation failure, early termination, detachment, packaging defect, performance concern or other issue before or during the Maximum Wear Period. Assessment is based on the available information, Sensor Identification Data, purchase details, photographs, screenshots or technical information where reasonably required, the IFU, product labelling, this Policy, the General Delivery Terms and mandatory applicable law.

S.5 A replacement may be provided where Maralvion determines, following reasonable review, that the issue is reasonably supported as being caused by a Sensor-related defect, malfunction, confirmed lack of conformity or another circumstance for which replacement is required or appropriate under this Policy or mandatory applicable law.

S.6 A Sensor will not normally qualify for free replacement where the available information reasonably indicates that the issue was caused or materially contributed to by incorrect application, unsuitable placement, inadequate skin preparation, failure to follow applicable overlay patch instructions, reuse or attempted reapplication, handling damage, external impact, pulling, snagging, pressure, tight clothing, sport, exercise, work activities, storage or transport outside the permitted conditions, use after expiry, deliberate or elective removal, an unsupported App or mobile device environment, disabled permissions, restrictive device settings, connectivity issues or use outside the IFU, intended purpose or applicable safety instructions.

S.7 Detachment or adhesive weakening will not normally qualify for replacement where it results from external circumstances such as sweating, prolonged or repeated water exposure, chlorinated swimming pool water, hot tubs, jacuzzis, saunas, steam rooms, salt water, oils, lotions, sunscreen, adhesive removers, heat, humidity, steam, clothing, impact, bumping, pulling or other conditions that may weaken adhesion or affect Sensor use, unless Maralvion determines that a confirmed product-related adhesive defect, confirmed lack of conformity or mandatory legal remedy applies.

S.8 Temporary signal interruptions, temporary App issues, recoverable Sensor errors, isolated missing values that resolve in accordance with the IFU, App or official support instructions, expected CGM variation, differences from a fingerstick blood glucose reading, laboratory value or another glucose monitoring system, or normal end-of-use behaviour do not by themselves establish a Sensor defect or replacement entitlement.

S.9 Where the conditions of this Policy are met, the normal remedy is one replacement Sensor for the affected Sensor. A replacement does not create a separate commercial durability guarantee, extend the Maximum Wear Period, extend a Subscription or entitle the Customer or User to compensation for unused Sensor time, alternative monitoring costs, premium delivery or other costs, unless mandatory applicable law requires otherwise.

S.10 This summary highlights key points only. It does not replace the full Sensor Replacement Policy, the General Delivery Terms, the Returns and Refund Policy, the App EULA, the Website EULA and Terms of Use, the App Legal Disclaimer, the Website Legal Disclaimer, the Privacy Policy, the IFU, product labelling, App warnings, safety notices, mandatory product information or any mandatory consumer rights, statutory conformity rights, product liability rights, medical device obligations or data protection rights that apply.

ARTICLE 1. DEFINITIONS

1.1 In this Sensor Replacement Policy, the following terms have the meanings set out below. References to “this Policy” mean this Sensor Replacement Policy. Capitalised terms not defined in this Policy have the meaning given to them in the General Delivery Terms or another applicable Legal Document, unless the context requires otherwise.

1.2 “Account” means a user or customer account created or used through the Website, webshop, App or related account environment to place or manage orders, access support features, submit requests or use related GlucoSensor™ Q services.

1.3 “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, support functionality and other digital features.

1.4 “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 for GlucoSensor™ Q, where and to the extent indicated in the applicable regulatory documentation.

1.5 “Authorised Service Providers” means affiliated companies and third party service providers engaged by Maralvion to support customer service, technical support, fulfilment, warehousing, logistics, quality management, regulatory compliance, legal matters, administration or related activities.

1.6 “Device” means the GlucoSensor™ Q System where that term is used in the context of CE marking, medical device law, the applicable certificate, product labelling, the Instructions for Use, manufacturer approved regulatory documentation or mandatory product information.

1.7 “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.

1.8 “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.

1.9 “Instructions for Use” or “IFU” means the manufacturer approved instructions, warnings, precautions, contraindications, operating requirements, placement requirements, compatibility requirements, storage requirements, troubleshooting instructions, disposal instructions and other safety information supplied with or made available for GlucoSensor™ Q.

1.10 “Legal Documents” means the General Delivery Terms, the Website EULA and Terms of Use, the App EULA, the Privacy Policy, the Returns and Refund Policy, this 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.

1.11 “Manufacturer SDK” means software development kit components, interfaces, libraries, communication protocols and related manufacturer controlled software used to connect the App with the GlucoSensor™ Q System and support System functionality, as supplied, authorised or specified by Dreisam.

1.12 “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 and NIP 7831951730.

1.13 “Maximum Wear Period” means the maximum intended period during which a Sensor may be worn following successful activation, being up to fourteen (14) days, subject to the IFU, product labelling, correct application and activation, Sensor adhesion, App functionality, individual use conditions, environmental conditions, external factors and safety considerations. The Maximum Wear Period describes the maximum intended wear duration and does not, by itself, create an automatic right to replacement, refund, credit or compensation merely because a Sensor did not remain usable for the full fourteen (14) day period. Any issue occurring before the end of the Maximum Wear Period will be assessed in accordance with this Policy, the IFU, product labelling and mandatory applicable law.

1.14 “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.

1.15 “Replacement Request” means a request for replacement of a Sensor because of an alleged defect, malfunction, activation failure, early termination, detachment, packaging defect, performance concern or other reported issue.

1.16 “Sensor” means the disposable GlucoSensor™ Q sensor assembly with an integrated transmitter, supplied in or with an applicator and intended to be applied, activated, worn, used, removed and disposed of in accordance with the IFU. Each Sensor is intended for single use. GlucoSensor™ Q does not use or require a separate reusable transmitter.

1.17 “Sensor Identification Data” means the lot number, serial number, UDI, QR code, packaging information, activation information or other product identifier that allows the relevant Sensor and production batch to be identified.

1.18 “Sensor Placement Sites” means the body locations approved for Sensor placement in the applicable IFU and manufacturer approved product information.

1.19 “User” means the individual who uses or is intended to use GlucoSensor™ Q, or on whose behalf a Replacement Request is submitted. The Customer and the User may be the same person, but they are not always the same person.

1.20 “Website” means the GlucoSensor website, webshop and related online Account environment operated by or on behalf of Maralvion.

1.21 “Customer” means any person or entity that purchases or orders a Sensor through an Official GlucoSensor Sales Channel.

1.22 “Consumer” means a natural person acting for purposes that are wholly or mainly outside that person’s trade, business, craft or profession.

1.23 “CGM Data” means glucose readings, glucose trends, trend indicators, glucose alerts, Time in Range information, reports, Sensor session information and related glucose information generated by or through the GlucoSensor™ Q System.

1.24 “Customer Support” means support provided through official GlucoSensor support channels by Maralvion or by an Authorised Service Provider acting on behalf of Maralvion.

1.25 “Health Data” means Personal Data relating to the physical or health status of an individual, including glucose readings, glucose trends, glucose alerts, Time in Range information, Sensor generated glucose information, health related reports, health related analytics, health related user entries, support information containing health details and related information.

1.26 “MDR” means Regulation (EU) 2017/745 on medical devices.

1.27 “Personal Data” means any information relating to an identified or identifiable natural person.

1.28 “Sensor Data” means technical, operational, performance related or identification data relating to a Sensor or Sensor session, including Sensor Identification Data, activation information, session status, performance information, error information, replacement information, support information and related technical or operational information. Sensor Data may also constitute Health Data where it relates to or reveals the health status of an identified or identifiable individual.

1.29 “Serious Incident” means an incident related to GlucoSensor™ Q that directly or indirectly led, might have led or might lead to: (a) the death of a patient, User or other person; (b) the temporary or permanent serious deterioration of a patient’s, User’s or other person’s state of health; or (c) a serious public health threat, within the meaning of applicable medical device law.

1.30 “Subscription” means a recurring purchase, recurring order or scheduled delivery arrangement for Sensors or other GlucoSensor™ Q products offered by Maralvion under the General Delivery Terms.

ARTICLE 2. SCOPE, LEGAL EFFECT AND MANDATORY RIGHTS

2.1 This Policy governs the practical assessment and handling of Replacement Requests concerning Sensors purchased directly from Maralvion through Official GlucoSensor Sales Channels. Maralvion may expressly confirm that this Policy also applies to a Sensor obtained through another specified sales channel.

2.2 A Replacement Request may be submitted by the Customer, the User or a person authorised to act on behalf of the Customer or User. Maralvion may request reasonable information or verification to establish the identity, purchase details or authority of the person submitting the request.

2.3 Where a Sensor was purchased from an independent retailer, reseller, marketplace seller or other third party, the Customer’s contractual and statutory sales claims must normally be addressed to that seller. Without assuming that seller’s contractual obligations, Maralvion may provide technical assistance, product complaint handling, regulatory cooperation or a discretionary goodwill replacement where Maralvion considers this appropriate.

2.4 Unless mandatory law provides otherwise, this Policy does not apply to Sensors obtained through private resale, unauthorised resale, unauthorised marketplace sellers or other sales channels not approved by Maralvion.

2.5 This Policy governs Sensor replacement assessment. It does not govern statutory withdrawal rights, ordinary returns of unopened Products, refunds unrelated to a reported Sensor issue, subscription cancellation, delivery issues, App licensing, Account access, medical advice, treatment decisions, personal injury claims, product liability claims or claims for damages. Those matters are governed by applicable law and the relevant Legal Documents.

2.6 This Policy supplements and does not exclude, restrict or replace any mandatory statutory right, remedy, obligation or liability under applicable consumer protection law, product conformity law, product liability law, medical device law or other mandatory applicable law. Where mandatory law provides a stronger or non-waivable right or remedy, that law prevails to the extent of the conflict.

2.7 This Policy does not provide a separate commercial durability guarantee for the full Maximum Wear Period and does not create an automatic replacement entitlement solely because a Sensor did not remain usable until the end of that period. Where a Sensor fails, malfunctions or appears not to conform before the end of the Maximum Wear Period, the matter will be assessed under this Policy, the General Delivery Terms and mandatory applicable law. This Article does not affect any mandatory statutory conformity rights that apply to the relevant Sensor.

2.8 The provision of troubleshooting, technical assistance, a replacement Sensor, a goodwill replacement or another practical solution does not, by itself, constitute an admission that the Sensor was defective, non-conforming or unsafe, that the Sensor caused any loss, injury or damage, or that Maralvion, Dreisam, the Authorised Representative or an Authorised Service Provider accepts liability.

2.9 The commercial assessment of a Replacement Request is separate from the assessment and handling of a product complaint, suspected incident, Serious Incident, safety concern, vigilance matter or information relevant to post market surveillance. Approval or rejection of a Replacement Request does not, by itself, determine whether a regulatory complaint or reportable event has occurred.

2.10 Except where a mandatory legal remedy applies, a User is entitled to a replacement only where the applicable conditions of this Policy are satisfied or where Maralvion elects to provide a replacement as a voluntary goodwill measure.

ARTICLE 3. COMMERCIAL AND REGULATORY ROLES

3.1 Maralvion is the seller, contracting party, EU importer, inventory holder and customer-facing economic operator for Sensors sold directly by Maralvion through Official GlucoSensor Sales Channels.

3.2 Within this Policy, Maralvion receives and administers Replacement Requests, communicates with Customers and Users, collects relevant information and evidence, performs or coordinates customer support and commercial assessment, determines whether the conditions of this Policy have been satisfied and fulfils approved replacements. Maralvion also remains responsible for the mandatory legal obligations that apply to Maralvion within its own role as seller and EU importer.

3.3 Dreisam is the legal Manufacturer of the GlucoSensor™ Q System. Within the Manufacturer’s role, Dreisam remains responsible for Device design, manufacture, risk management, Sensor technology, core Sensor performance, the Manufacturer SDK, manufacturer controlled software components, technical documentation, clinical evaluation, conformity assessment, CE marking, product labelling, the IFU, post market surveillance, vigilance, corrective action and other obligations assigned to the Manufacturer under the MDR and applicable medical device law.

3.4 Firsteck Bio S.r.l. acts as Authorised Representative of the Manufacturer within the European Union, where and to the extent indicated in the applicable regulatory documentation. The Authorised Representative performs the tasks accepted under its written mandate from the Manufacturer and the obligations assigned to an authorised representative under applicable medical device law.

3.5 Maralvion may use Authorised Service Providers to assist with customer support, technical review, data collection, complaint administration, warehousing, fulfilment, shipment of replacement Sensors, regulatory support, legal support or related operational activities. The use of an Authorised Service Provider does not transfer or alter the regulatory role or mandatory legal obligations of Maralvion, the Manufacturer or the Authorised Representative and does not create a direct contractual relationship between the User and that Authorised Service Provider unless expressly stated otherwise.

3.6 Maralvion is not the Manufacturer of the Device and does not independently design, manufacture, clinically evaluate, validate, modify or alter the Sensor, the Manufacturer SDK, the underlying glucose measurement algorithm, Sensor calculation logic, calibration logic, measurement logic or manufacturer controlled medical measurement functionality.

3.7 Nothing in this Policy limits or transfers any mandatory legal obligation or liability imposed on Maralvion within its own role, on Dreisam within the Manufacturer’s role or on Firsteck Bio S.r.l. within the Authorised Representative’s role.

3.8 Maralvion may reasonably rely on technical information, product records, diagnostic information and assessments supplied by Dreisam, the Authorised Representative or Authorised Service Providers when assessing a Replacement Request. A decision by Maralvion under this Policy is a commercial support determination based on the information reasonably available at the time. It does not replace any regulatory root cause analysis, product safety assessment, vigilance determination or decision that must be made by the Manufacturer, the Authorised Representative or a competent authority within their respective roles.

ARTICLE 4. REPLACEMENT ELIGIBILITY

4.1 A Sensor is a single use disposable component of the GlucoSensor™ Q System intended for a maximum wear period of up to fourteen (14) days following successful activation, when correctly applied, activated, worn and used in accordance with the IFU, product labelling, App instructions and applicable Legal Documents. “Up to fourteen (14) days” is an outer limit of intended use and not a separate commercial guarantee that each individual Sensor will remain continuously usable for the full period. The actual usable duration of an individual Sensor may be affected by activation, adhesion, individual use conditions, App and mobile device functionality, connectivity, environmental conditions, physiological factors, safety considerations and other circumstances described in the IFU or this Policy.

4.2 Subject to mandatory applicable law, a Sensor may qualify for a replacement under this Policy only where Maralvion determines, following reasonable assessment, that all of the following conditions have been satisfied: (a) the Sensor was purchased directly from Maralvion through an Official GlucoSensor Sales Channel; (b) the reported issue occurred before use, during activation or during the Maximum Wear Period; (c) the Replacement Request was submitted without undue delay after the issue became known, preferably within seven (7) days; (d) the Customer or User provided the information and evidence reasonably required under Article 5; (e) the Sensor was stored, applied, activated, worn and used in accordance with the IFU and applicable product instructions; and (f) the available information reasonably supports the conclusion that the issue resulted from a Sensor related defect or malfunction and not from an excluded cause under Article 6.

4.3 Issues that may qualify for replacement include: (a) a visible manufacturing defect, product defect or packaging defect identified before use; (b) failure of the Sensor to activate after correct application and completion of the activation procedure described in the IFU and App instructions; (c) a persistent Sensor error that does not resolve following any applicable waiting period, recovery process or troubleshooting procedure described in the IFU, App or official support instructions; (d) permanent cessation of Sensor functionality materially before the Maximum Wear Period is reached, where the available information reasonably supports that the cessation resulted from an inherent Sensor related technical fault and not from normal end of use behaviour, user handling, adhesion, placement, connectivity, mobile device settings, environmental exposure or another excluded cause; (e) a product performance issue confirmed through appropriate technical assessment as falling outside applicable manufacturer approved specifications; or (f) another confirmed product, quality or safety issue for which Maralvion, the Manufacturer or the Authorised Representative determines that replacement is appropriate.

4.4 A Sensor does not qualify for replacement merely because it did not remain usable for the full Maximum Wear Period. A Sensor that has provided substantially all of its intended use, or that stops functioning close to the end of the Maximum Wear Period, will not normally qualify for a voluntary commercial replacement, pro rata credit, Subscription extension or compensation for unused Sensor time unless Maralvion determines, following reasonable review, that there is a confirmed product defect, a confirmed lack of conformity or a mandatory legal remedy applies.

4.5 A temporary signal interruption, temporary loss of displayed glucose information, recoverable Sensor error, temporary App issue or other temporary interruption does not qualify for replacement where the Sensor subsequently resumes normal operation within the period or following the procedure stated in the IFU, App or official support instructions.

4.6 Where a replacement is approved under this Policy, the normal remedy is one replacement Sensor for the affected Sensor. Maralvion may provide a Sensor of the same model or, where the same model is unavailable, a compatible, functionally equivalent and manufacturer approved successor or replacement Sensor.

4.7 Unless mandatory law requires another remedy, approval of a replacement under this Policy does not create an entitlement to a cash refund, purchase price reduction, pro rata credit, subscription credit, extension of a Subscription, reimbursement of alternative monitoring costs, compensation for unused Sensor time or reimbursement of any other cost, loss or expense.

4.8 Only one replacement may be provided in respect of each affected Sensor. A replacement Sensor does not extend the Maximum Wear Period of the original Sensor, create or renew a separate commercial guarantee, or extend a Subscription or other commercial benefit. The existence, commencement, suspension, interruption, extension or renewal of any statutory conformity, limitation or liability period in relation to the original Sensor or a replacement Sensor is determined exclusively by mandatory applicable law. Any separate issue involving a replacement Sensor will be assessed independently under this Policy and mandatory applicable law.

4.9 Approval of a replacement for one Sensor does not establish that another Sensor, production lot, reported issue or future Replacement Request will qualify for replacement. Each Replacement Request is assessed on its own facts, available evidence and applicable legal requirements.

ARTICLE 5. REPLACEMENT REQUEST PROCEDURE AND REQUIRED INFORMATION

5.1 A Replacement Request must be submitted through an official GlucoSensor support channel, including by email to support@glucosensor.com, unless Maralvion designates another support channel for the relevant country or request.

5.2 The Customer or User must provide the information reasonably necessary to identify the Sensor, verify the purchase, understand the reported issue and assess replacement eligibility. Depending on the nature of the request, this information may include: (a) the Customer’s or User’s name and contact details; (b) the Account email address; (c) the order number and proof of purchase; (d) the country of purchase and delivery; (e) the purchase channel; (f) the Sensor Identification Data; (g) clear photographs of the Sensor, applicator, packaging, labels and reported defect; (h) the activation date and approximate activation time; (i) the date and approximate time when the issue occurred; (j) a complete description of the issue; (k) App screenshots, error messages or relevant technical information; (l) the mobile device model, operating system version and App version; (m) the Sensor Placement Site; (n) relevant information concerning application, skin preparation, adhesion, overlay patch use, physical activity, water exposure or external impact; (o) troubleshooting steps already completed; and (p) other information reasonably required for replacement assessment, technical investigation, quality management, product complaint handling, regulatory compliance or fraud prevention.

5.3 Information requested under Article 5.2 must be provided only to the extent that it is reasonably available, relevant to the reported issue and necessary for the assessment. Maralvion may request additional or clarifying information where the information initially supplied is incomplete, inconsistent, unclear or insufficient to determine the likely cause of the issue.

5.4 For a complaint concerning glucose information, Sensor performance or an alleged difference between Sensor information and another glucose measurement, Maralvion may request relevant App screenshots, glucose trends, trend arrows, exact comparison times, information concerning the comparison method, the type of reference device used, relevant reference readings, the timing of meals, medication, exercise or rapidly changing glucose values and any other information reasonably necessary to assess the reported difference. Providing such information does not mean that Maralvion provides medical advice or independently validates the medical accuracy of any measurement.

5.5 The Customer and User must cooperate reasonably with the assessment process and must provide information that is accurate, complete and not misleading. Information, photographs, screenshots, Sensor data, documents or descriptions must not be altered, manipulated or presented in a way that could create an incorrect impression of the reported issue.

5.6 If required information is missing, Maralvion may suspend the assessment and request that the missing information be provided within a reasonable period. Maralvion may close or reject the Replacement Request if the requested information is not provided and the request cannot reasonably be assessed without that information. This does not limit any mandatory right that may be established through other sufficient evidence.

5.7 The Customer or User should retain the affected Sensor, applicator, packaging, labels and other relevant materials, where safe and reasonably practicable, until Maralvion confirms that they are no longer required for assessment. The Sensor and related materials must be stored and handled safely and must not be reused, altered, opened, repaired or tampered with.

5.8 A used Sensor, applicator or other material that may contain biological material must not be returned or sent to Maralvion, the Manufacturer, the Authorised Representative or an Authorised Service Provider unless Maralvion expressly requests the return and provides appropriate hygiene, packaging, shipping and handling instructions.

5.9 Where return of a Sensor, packaging, applicator or other material is reasonably required, the Customer or User must follow the return instructions provided by Maralvion. Maralvion will arrange or bear reasonable return costs where required by mandatory law or where Maralvion expressly confirms that the return will be made at Maralvion’s expense.

5.10 Maralvion may review information lawfully available to it through the Account, order records, customer support systems, technical support systems or other systems used for a permitted purpose. Because certain App information, Sensor information, CGM Data or Health Data may be stored locally on the User’s mobile device and may not be routinely accessible to Maralvion, the Customer or User may be required to provide relevant screenshots, exports, diagnostic information or technical records. Submission of a Replacement Request does not give Maralvion unrestricted access to the User’s mobile device or to all information stored in or through the App. Personal Data, Health Data and technical information will be processed in accordance with the Privacy Policy and applicable data protection law.

5.11 Maralvion may suspend, reject or investigate a Replacement Request further where there are objectively reasonable indications of fraud, abuse, resale, repeated unsupported requests, irregular replacement patterns, manipulation of information, deliberate damage, misuse of the support process, use of multiple Accounts or identities to obtain duplicate or unjustified replacements, or another attempt to obtain a replacement without a valid basis.

5.12 Maralvion may combine or cross reference related Replacement Requests, complaints, orders, Accounts, Sensor Identification Data and support records where reasonably necessary to prevent duplicate replacements, investigate repeated issues, identify potential fraud, fulfil legal obligations or support product safety and quality management.

ARTICLE 6. EXCLUSIONS FROM REPLACEMENT

6.1 Subject to mandatory applicable law, a Sensor does not qualify for replacement under this Policy to the extent that the available information reasonably demonstrates that the reported issue was caused or materially contributed to by user handling, use outside the IFU, an external factor, an incompatible technical environment or another circumstance for which an inherent Sensor related defect has not been established.

6.2 Application, placement and adhesion related exclusions include: (a) application to a location that is not an approved Sensor Placement Site; (b) application contrary to the IFU or official application instructions; (c) incorrect or incomplete use of the applicator; (d) application to skin that was not prepared in accordance with the IFU; (e) application to wet, unsuitable, irritated or damaged skin where this is contrary to the IFU; (f) the presence of lotion, oil, cream, sunscreen, adhesive remover, moisture, excessive hair, dirt or another substance that may interfere with correct application or adhesion; (g) failure to follow an overlay patch requirement expressly stated in the IFU or instructions supplied with the Sensor; or (h) interference with the Sensor or adhesive during or immediately after application.

6.3 Handling and external exposure exclusions include: (a) physical impact, bumping, pulling, snagging, pressure, compression or accidental damage; (b) tight clothing, straps, protective equipment or other items pressing against or catching the Sensor; (c) sport, exercise, work activities or other physical activities that dislodge or damage the Sensor; (d) water, heat, humidity, steam, sweat, chemicals or environmental exposure outside the conditions permitted by the IFU or product labelling, including prolonged or repeated water exposure, chlorinated swimming pool water, hot tubs, jacuzzis, saunas, steam rooms, salt water, oils, lotions, sunscreen, adhesive removers or other substances or conditions that may weaken adhesion or affect Sensor performance, where such exposure caused or materially contributed to the reported issue; (e) storage, transport or handling outside the conditions stated in the IFU or product labelling after delivery to the Customer; (f) use after the expiry date; (g) use despite visible damage, opened packaging or compromised sterile packaging; (h) deliberate or elective removal; (i) removal for a medical procedure, imaging procedure, treatment, sport, travel, work requirement or personal preference; (j) reapplication or attempted reapplication; or (k) opening, modifying, repairing, dismantling, damaging or tampering with the Sensor or applicator.

6.4 App, mobile device and connectivity related exclusions include: (a) use with an incompatible or unsupported mobile device or operating system; (b) use of an unsupported, outdated, unofficial or modified App; (c) use of a rooted, jailbroken or otherwise altered mobile device where this affects functionality or safety; (d) disabled Bluetooth, disabled App permissions, restricted background activity, battery saving restrictions, disabled notifications or other mobile device settings that interfere with System functionality; (e) insufficient mobile device battery, storage capacity or system resources; (f) keeping the mobile device outside the applicable communication range; (g) loss of internet connectivity where internet access is required for the relevant function; (h) mobile device failure, operating system failure or third party software interference; or (i) temporary signal gaps, communication interruptions or display issues that are not caused by a verified Sensor defect.

6.5 A difference between Sensor information and a fingerstick blood glucose reading, laboratory value or another glucose monitoring system does not by itself establish that the Sensor is defective. Reported differences may be influenced by timing, physiological lag between interstitial glucose and blood glucose, rapidly changing glucose values, trend direction, the comparison method, the reference device, compression, hydration, skin condition, body temperature, physical activity, environmental conditions, medicines, substances or medical conditions identified in the IFU as potentially affecting Sensor performance, and other factors relevant to CGM performance.

6.6 Expected variation, temporary interruption, isolated missing values, a recoverable error, a temporary connection issue or another characteristic falling within the limitations, warnings or performance information stated in the IFU or applicable manufacturer approved product information does not qualify as a Sensor defect merely because the User expected a different result.

6.7 Use outside the intended purpose, intended user group, contraindications, warnings, limitations or operating conditions stated in the IFU or applicable regulatory documentation may result in rejection where that use caused or materially contributed to the reported issue. This includes use by a person under eighteen (18) years of age, use for an unapproved purpose or use contrary to a safety related instruction.

6.8 A Sensor does not qualify for replacement under this Policy where it was lost, stolen, resold, supplied through private resale, obtained through an unauthorised sales channel, used in connection with unauthorised commercial redistribution or deliberately discarded without a reasonable hygiene or safety justification before information or evidence reasonably required for assessment could be preserved. A Sensor is not excluded solely because it was purchased by a Customer for an identified User, including a household member, provided that the purchase and use otherwise comply with this Policy, the IFU and the applicable Legal Documents. Nothing in this Article prevents Maralvion from performing any product safety or regulatory action required by applicable law.

6.9 Early removal because of discomfort, skin irritation, a skin reaction, concern about adhesion, personal preference or advice relating to an individual medical circumstance does not automatically establish a Sensor defect or replacement entitlement. Maralvion may nevertheless record, assess or forward the information as a product complaint, safety related report or matter relevant to post market surveillance.

6.10 The existence of an exclusion under this Article does not prevent Maralvion, the Manufacturer or the Authorised Representative from investigating the matter as a product complaint, technical complaint, quality issue, suspected incident or safety concern. Commercial replacement eligibility and regulatory complaint handling remain separate assessments.

ARTICLE 7. SENSOR ADHESION, DETACHMENT AND PLACEMENT

7.1 Sensor adhesion may be affected by Sensor Placement Site, skin condition, skin preparation, application technique, physical activity, sweating, water exposure, temperature, clothing, external pressure, impact, individual skin characteristics and other circumstances that are not fully within the control of Maralvion or the Manufacturer. Detachment does not by itself establish that the Sensor or adhesive was defective.

7.2 The User must apply the Sensor only to an approved Sensor Placement Site and must follow all placement, skin preparation, application, adhesion and aftercare instructions stated in the IFU and official product instructions. The User must ensure that the selected site and skin condition are suitable for application in accordance with those instructions.

7.3 Where the IFU or official product instructions require the use of an overlay patch in the relevant circumstances, the User must apply and maintain the overlay patch in accordance with those instructions. Where an overlay patch is recommended but not required, failure to use it does not by itself exclude replacement eligibility, but Maralvion may consider that circumstance together with the other available information when determining the likely cause of detachment. An overlay patch must not be applied in a manner that obstructs, damages, moves or places inappropriate pressure on the Sensor.

7.4 Detachment will not normally qualify for replacement where the available information reasonably indicates that it resulted from incorrect application, unsuitable placement, inadequate skin preparation, failure to follow an applicable overlay patch instruction, physical impact, bumping, pulling, snagging, pressure, clothing, sport, exercise, work activities, sweating, water exposure, chlorinated swimming pool water, hot tubs, jacuzzis, saunas, steam rooms, salt water, environmental conditions, deliberate removal or another external circumstance.

7.5 Detachment may qualify for replacement where the Customer or User followed the applicable placement, preparation, application and adhesion instructions and the available information reasonably supports the existence of a product related adhesive defect, applicator defect, manufacturing defect or other inherent Sensor related issue.

7.6 Maralvion may request photographs of the placement location, detached Sensor, adhesive surface, applicator, packaging and Sensor Identification Data, together with information concerning the time of detachment, activity, clothing, water exposure, skin preparation and overlay patch use, where reasonably necessary to determine the likely cause of detachment.

7.7 A Sensor that has detached or has been removed must not be reapplied, repositioned or reused. Attempted reapplication or reuse may compromise Sensor performance, hygiene, safety and regulatory conformity and will normally exclude replacement for any issue arising after the attempted reapplication or reuse.

7.8 Swimming, bathing, showering, sweating, sport, hot tubs, jacuzzis, saunas, steam rooms, salt water, chlorinated water and similar conditions may increase the risk of Sensor detachment or adhesive weakening. Detachment caused or materially contributed to by such circumstances will not normally qualify for replacement, unless Maralvion determines that a confirmed product-related adhesive defect, confirmed lack of conformity or mandatory legal remedy applies.

ARTICLE 8. APP, TECHNICAL DATA AND PERFORMANCE REVIEW

8.1 To assess a Replacement Request, Maralvion may use information lawfully available to it or lawfully provided by the Customer or User, including order records, Account information, customer support records, Sensor Identification Data, activation information, Sensor session information, error codes, screenshots, photographs, App version information, mobile device information, operating system information, connectivity information, relevant mobile device settings, diagnostic information, technical records and information supplied by the Manufacturer, the Authorised Representative or an Authorised Service Provider.

8.2 Maralvion will request and process only information that is reasonably relevant and proportionate to the assessment, technical investigation, product complaint, quality review, regulatory obligation, fraud prevention purpose or legal claim concerned. The information required may differ depending on the nature, complexity and potential safety relevance of the reported issue.

8.3 Certain App information, Sensor information, CGM Data and Health Data may be processed and stored locally on the User’s mobile device and may not be routinely accessible to Maralvion. Where such information is reasonably necessary for the assessment, the Customer or User may be asked to provide selected screenshots, reports, exports, error information or diagnostic records. Maralvion is not required to access, copy or review information that is not reasonably necessary for the relevant purpose.

8.4 A technical review may be used to assess whether the reported issue is more likely to relate to the Sensor, applicator, adhesive, App, Manufacturer SDK, manufacturer controlled software, mobile device compatibility, operating system, Bluetooth connection, internet connection, permissions, notification settings, battery restrictions, user handling, placement, environmental exposure, physiological factors or another relevant cause.

8.5 Maralvion may provide relevant information to the Manufacturer, the Authorised Representative or an Authorised Service Provider where reasonably necessary and legally permitted for technical assessment, product complaint investigation, quality management, post market surveillance, vigilance, replacement fulfilment, fraud prevention, regulatory compliance or the establishment, exercise or defence of legal claims.

8.6 Maralvion may reasonably rely on technical information, product specifications, diagnostic findings and assessments supplied by the Manufacturer or the Authorised Representative, provided that this does not limit Maralvion’s own mandatory obligations as seller or EU importer.

8.7 Where a definitive technical root cause cannot reasonably be established, Maralvion may determine replacement eligibility on the basis of all information and evidence reasonably available at the time. Technical uncertainty does not by itself create an automatic right to replacement under this Policy. This Article does not alter any statutory presumption, burden of proof or mandatory conformity right that applies under applicable law.

8.8 A technical assessment, troubleshooting process, replacement approval, replacement rejection or referral for further investigation is not medical advice, does not constitute a medical diagnosis and does not by itself constitute a final regulatory determination concerning Device safety, conformity, reportability or root cause.

8.9 Maralvion will normally communicate the principal reason for approving or rejecting a Replacement Request. Except where mandatory law requires otherwise, Maralvion is not required to disclose proprietary diagnostic methods, confidential manufacturer information, algorithms, internal quality criteria, internal risk thresholds, fraud prevention methods, trade secrets, legally privileged information, regulatory documentation subject to confidentiality restrictions or Personal Data relating to another person.

8.10 The collection, use, disclosure, transfer, storage, retention and deletion of Personal Data, Health Data, Sensor Data, CGM Data and technical information are governed by the Privacy Policy and applicable data protection law. In the event of inconsistency concerning privacy or data protection, the Privacy Policy prevails for that subject matter.

ARTICLE 9. ASSESSMENT OUTCOME, REMEDY AND FULFILMENT

9.1 Maralvion will assess a Replacement Request reasonably on the basis of the information and evidence available, the IFU, product labelling, this Policy, the applicable Legal Documents, applicable law and any relevant technical input from the Manufacturer, the Authorised Representative or an Authorised Service Provider.

9.2 The description or label used by the Customer or User does not determine the legal nature of the request. Where the information reasonably indicates that the matter may constitute a statutory conformity claim, product complaint, safety related report or another legally regulated matter, Maralvion may assess and handle the matter under the General Delivery Terms, applicable law or the relevant regulatory process, whether or not the Customer or User expressly referred to that legal basis.

9.3 Following assessment, Maralvion may:

(a) approve a replacement under this Policy;

(b) request additional information or evidence;

(c) request completion of relevant troubleshooting steps;

(d) provide application, technical or educational guidance consistent with the IFU;

(e) handle the matter as a statutory conformity claim under the General Delivery Terms and mandatory applicable law;

(f) offer a goodwill replacement under Article 10;

(g) reject the Replacement Request;

(h) record or escalate the matter as a product complaint, technical complaint, quality matter, safety related report or matter relevant to post market surveillance or vigilance; or

(i) take another action reasonably required by applicable law or the circumstances of the request.

9.4 Maralvion will seek to complete the assessment within a reasonable period, taking into account the information available, the complexity of the issue, the need for technical or regulatory review, any information required from the Customer or User and any input required from the Manufacturer or the Authorised Representative. Where mandatory law prescribes a specific period or standard for a statutory remedy, that mandatory requirement applies.

9.5 Where information reasonably required for the assessment has not been provided, Maralvion may suspend the assessment until the information is received. Any resulting delay will not be attributed to Maralvion to the extent that the delay was reasonably caused by the missing information, lack of cooperation or circumstances outside Maralvion’s reasonable control. This does not affect any mandatory period that cannot lawfully be suspended or extended.

9.6 Maralvion will normally communicate the assessment outcome through the email address associated with the relevant Account or Replacement Request, or through another official support channel. Maralvion may require reasonable identity, Account, delivery address or purchase verification before disclosing information or fulfilling an approved replacement.

9.7 Where replacement is required as a statutory conformity remedy, the replacement will be provided free of charge and under the conditions required by mandatory applicable law. Where a replacement is approved under this Policy, Maralvion will provide the replacement Sensor without charge and will normally bear the cost of standard delivery to an eligible address within a supported market. Expedited delivery, premium delivery, delivery outside supported markets or a delivery method requested by the Customer or User may be unavailable or may be subject to additional costs where permitted by law and agreed in advance.

9.8 Maralvion may select the carrier, dispatch location, delivery method and reasonable fulfilment process. A replacement may consist of the same Sensor model or a compatible, functionally equivalent and manufacturer approved successor or replacement Sensor. The production lot, packaging, labelling or non-material presentation may differ, provided that the replacement may lawfully be supplied and is suitable for its intended use.

9.9 Maralvion may require the affected Sensor, applicator, packaging or other relevant material to be returned, retained, made available for collection, safely disposed of or photographed before or after fulfilment, where reasonably necessary and legally permitted. Used Sensors or materials containing biological material must be handled only in accordance with the hygiene, packaging, return and disposal instructions supplied by Maralvion.

9.10 Fulfilment may be delayed, modified or prevented by stock availability, a product withdrawal, recall, field safety corrective action, legal restriction, regulatory restriction, transport restriction, sanctions requirement, medical device distribution requirement, force majeure event or another circumstance outside Maralvion’s reasonable control. Where a statutory remedy applies, Maralvion will provide any alternative remedy required by mandatory law. A discretionary goodwill replacement may be postponed or withdrawn where fulfilment is not reasonably possible.

9.11 Maralvion may cancel an approved but unshipped replacement, suspend fulfilment or seek return of the replacement or reimbursement of its reasonable value where approval was obtained through fraud, deliberate misrepresentation, manipulated evidence, concealment of material information or a duplicate claim. Any action under this Article is subject to applicable law and must be proportionate to the circumstances.

ARTICLE 10. GOODWILL REPLACEMENTS

10.1 Where a Sensor does not qualify for replacement under Article 4 and no mandatory statutory remedy applies, Maralvion may offer a goodwill replacement in exceptional circumstances.

10.2 A goodwill replacement is voluntary and discretionary. Maralvion is not required to provide a goodwill replacement merely because a Sensor did not remain usable for the full Maximum Wear Period, because a previous request was approved or because another Customer or User received a goodwill replacement in different circumstances.

10.3 Goodwill replacements are normally limited to two (2) Sensors per User and Account in any rolling twelve (12) month period. Where reasonably necessary to prevent circumvention, duplicate requests, misuse or abuse, Maralvion may treat multiple Accounts controlled by the same Customer, multiple Accounts used by the same household for the same User, or multiple Accounts used to submit requests concerning the same User, as a single Account for the purpose of applying this limit.

10.4 A replacement provided because of a confirmed defect, confirmed lack of conformity or mandatory statutory remedy will not be treated as a goodwill replacement and will not be counted towards the limit in Article 10.3.

10.5 Maralvion may make a goodwill replacement subject to reasonable conditions, including completion of troubleshooting steps, review of application technique, review of Sensor Placement Site selection, review of skin preparation, provision of photographs or screenshots, confirmation that the IFU was followed, review of overlay patch use or completion of educational material intended to reduce repeated application, adhesion or handling issues.

10.6 A goodwill replacement does not constitute an admission of defect, nonconformity, product unsafety, fault, causation or liability. It does not create a legal entitlement, contractual commitment, established practice, legitimate expectation or binding precedent for another request.

10.7 Maralvion may refuse a goodwill replacement where there are repeated requests relating to detachment, application errors, unsupported failures, avoidable handling issues, excluded circumstances, incomplete information, resale, misuse, suspected fraud or failure to follow previous application or troubleshooting guidance.

10.8 Maralvion may amend, restrict, suspend or discontinue the goodwill replacement programme for future requests. Any such change does not affect a mandatory statutory right or a goodwill replacement already expressly approved and not obtained through fraud or material misrepresentation.

10.9 Classification of a replacement as goodwill does not prevent Maralvion, the Manufacturer or the Authorised Representative from separately recording, assessing or investigating the reported issue as a product complaint, quality matter or safety related report.

ARTICLE 11. PRODUCT COMPLAINTS, SAFETY REPORTS AND REGULATORY HANDLING

11.1 A Replacement Request may also contain information that qualifies as a product complaint, technical complaint, quality complaint, suspected malfunction, safety related report, suspected incident or information relevant to post market surveillance, vigilance, corrective action or regulatory compliance.

11.2 Commercial replacement assessment and regulatory complaint handling are separate processes. Approval or rejection of a replacement does not determine whether a product complaint, safety matter, reportable event, corrective action or regulatory investigation exists.

11.3 Maralvion may record, classify, retain, assess and forward relevant complaint or safety information to the Manufacturer, the Authorised Representative, an Authorised Service Provider, a competent authority or another legally authorised recipient where necessary or required for complaint handling, quality management, product traceability, post market surveillance, vigilance, regulatory reporting, corrective action, legal compliance or protection of Users.

11.4 The Customer and User must provide accurate and complete information reasonably requested in connection with a suspected product safety issue, injury, serious deterioration of health, medical intervention, applicator issue, broken or retained Sensor filament, suspected sterility concern, significant skin reaction, unexpected malfunction or other event that may require regulatory assessment.

11.5 Maralvion may contact the Customer or User for additional information after the commercial Replacement Request has been approved, rejected, closed or otherwise resolved. The Customer and User must cooperate reasonably with follow-up questions where the information is necessary for product safety, complaint investigation, post market surveillance, vigilance or another mandatory regulatory purpose.

11.6 Where a reported issue may affect safe or correct use, the User must follow the IFU, product labelling, App safety instructions and official safety communications. The affected Sensor must not be used or continued in use where the IFU, an App warning or an official safety instruction requires use to stop.

11.7 If a Sensor filament appears to have broken, remains in the body or cannot be removed in the ordinary manner described in the IFU, the User must not attempt invasive removal or reinsertion. The User must follow the IFU and seek qualified medical assistance where necessary.

11.8 A Replacement Request, customer support interaction or technical assessment is not an emergency service and does not replace professional medical advice, diagnosis, treatment or emergency care. Symptoms, urgent medical concerns or a possible medical emergency must be addressed in accordance with the IFU and through an appropriate healthcare professional or emergency service.

11.9 Regulatory complaint handling, safety assessment, investigation, record retention and lawful disclosure may continue after a replacement has been provided, after a Replacement Request has been rejected, after the affected Sensor has reached the end of use, after the Account has been closed or after the User has stopped using GlucoSensor™ Q, where necessary and legally permitted. Personal Data and Health Data will be handled in accordance with the Privacy Policy.

11.10 Nothing in this Policy excludes, restricts or replaces any mandatory product complaint, vigilance, serious incident reporting, recall, withdrawal, field safety corrective action, post market surveillance, competent authority cooperation or other product safety obligation imposed by applicable law.

ARTICLE 12. RELATIONSHIP WITH OTHER LEGAL DOCUMENTS

12.1 This Policy forms part of the broader legal framework governing the purchase, supply, use and support of GlucoSensor™ Q and must be read together with the applicable Legal Documents, the IFU, product labelling, safety notices and mandatory product information.

12.2 The IFU, product labelling, mandatory regulatory information and applicable safety notices govern the correct and safe use of GlucoSensor™ Q, including its intended purpose, intended user group, Sensor Placement Sites, application, activation, operation, warnings, precautions, contraindications, performance limitations, compatibility, storage, removal and disposal.

12.3 This Policy primarily governs:

(a) commercial replacement eligibility for an affected Sensor;

(b) the procedure for submitting and assessing a Replacement Request;

(c) the information and evidence reasonably required for that assessment;

(d) exclusions from commercial replacement eligibility;

(e) the practical fulfilment of an approved replacement; and

(f) discretionary goodwill replacements.

12.4 The General Delivery Terms and mandatory applicable law govern the sales contract, statutory conformity, statutory remedies, delivery, contractual liability, product related commercial claims, governing law and dispute resolution. Where a Customer or User has a statutory right to replacement, repair, price reduction, termination, refund or another remedy, that right is determined under the General Delivery Terms and mandatory applicable law rather than solely under the commercial eligibility conditions of this Policy.

12.5 The Returns and Refund Policy governs statutory withdrawal rights, voluntary returns where offered, return eligibility for unopened products, general return procedures and refund administration. A Replacement Request concerning an applied, activated or allegedly defective Sensor is governed primarily by this Policy, the General Delivery Terms and mandatory applicable law.

12.6 The App EULA and the Legal Disclaimer for the GlucoSensor™ Q App govern access to and use of the App, App functionality, digital content and digital services, App related technical requirements, alerts, Reports, Manufacturer SDK related functionality and applicable App use limitations. The Website EULA and Terms of Use and the Website Legal Disclaimer govern access to and use of the Website, webshop, Account environment and Website content.

12.7 The Privacy Policy governs the collection, use, disclosure, transfer, storage, retention, security and deletion of Personal Data, Health Data, CGM Data, Sensor Data and other information processed in connection with a Replacement Request, technical review, product complaint, safety report or regulatory investigation.

12.8 In the event of inconsistency between this Policy and another Legal Document, the document that most specifically governs the relevant subject matter applies to that subject matter. This Policy prevails for voluntary commercial replacement eligibility and replacement handling. The General Delivery Terms and mandatory applicable law prevail for statutory conformity rights and statutory remedies. The Privacy Policy prevails for privacy and data protection matters. The IFU, product labelling, mandatory regulatory information and safety notices prevail for matters concerning safe and correct use.

12.9 Nothing in this Article allows any Legal Document to exclude, restrict or reduce a mandatory right, remedy, obligation or liability that cannot lawfully be excluded, restricted or reduced.

ARTICLE 13. CHANGES AND VERSION CONTROL

13.1 Maralvion may update this Policy where there is a valid reason to do so, including changes in applicable law, consumer protection requirements, medical device requirements, product information, safety requirements, Manufacturer instructions, technical support processes, complaint handling processes, fraud prevention measures, fulfilment arrangements, service providers, customer support practices or business operations.

13.2 Unless mandatory law provides otherwise, the version of this Policy made available as part of the contractual framework applicable to the purchase of the relevant Sensor normally governs the substantive commercial replacement eligibility of that Sensor.

13.3 Maralvion may apply a later version of this Policy to an existing or subsequently submitted Replacement Request where:

(a) the later version provides a more favourable outcome for the Customer or User;

(b) the change is required by mandatory law, a competent authority, product safety requirements or applicable medical device obligations;

(c) the change concerns only administrative, evidential, technical or procedural requirements and does not materially reduce an existing contractual or statutory right; or

(d) the Customer or User expressly agrees to application of the later version where such agreement is legally valid.

13.4 Changes to the discretionary goodwill replacement programme may apply to goodwill requests submitted on or after the effective date of the updated Policy, including requests concerning Sensors purchased earlier, provided that the change does not affect a mandatory statutory right, an accrued contractual right or a goodwill replacement already expressly approved by Maralvion.

13.5 A product safety instruction, recall measure, field safety corrective action, regulatory restriction, competent authority instruction or other mandatory safety or regulatory measure may apply immediately to existing Sensors, pending Replacement Requests and approved but unfulfilled replacements where required by applicable law or reasonably necessary to protect Users.

13.6 The version number and effective date shown at the beginning of this Policy identify the applicable published version. Updated versions may be published through the Website, Account environment, App or another appropriate communication channel.

13.7 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 or another appropriate communication channel, where required by applicable law.

13.8 No update to this Policy will retroactively exclude or reduce a mandatory statutory right, remedy or protection that has already arisen in relation to a Sensor.

ARTICLE 14. INTERPRETATION, APPROVAL AND SEVERABILITY

14.1 Article headings are included for convenience and do not affect the interpretation of this Policy.

14.2 The words “including”, “includes”, “such as” and similar expressions are illustrative and do not limit the preceding words or the scope of the relevant provision.

14.3 Words in the singular include the plural and words in the plural include the singular where the context permits.

14.4 References to applicable law include that law as amended, replaced, supplemented or re-enacted, together with applicable implementing measures, regulatory requirements and legally binding decisions.

14.5 Troubleshooting guidance, a preliminary assessment, a request for additional information, creation of a support case, allocation of a case number, discussion of possible eligibility or an estimated shipment date does not by itself constitute final approval of a replacement. Approval is final only when Maralvion expressly confirms through an official GlucoSensor support channel that the relevant replacement has been approved.

14.6 A failure or delay by Maralvion to exercise or enforce a right, condition, exclusion or remedy under this Policy does not constitute a waiver of that right, condition, exclusion or remedy.

14.7 Any exception, discretionary decision or accommodation made by Maralvion applies only to the specific Replacement Request for which it is expressly granted. It does not amend this Policy, establish an entitlement, create a binding precedent or require Maralvion to make the same decision in another case.

14.8 If any provision of this Policy is found to be invalid, unlawful or unenforceable, that provision will be interpreted or limited to the minimum extent necessary to make it valid, lawful and enforceable while preserving its intended legal and commercial effect as far as possible.

14.9 If a provision cannot lawfully be interpreted or limited in that manner, it will be treated as severed to the necessary extent. The remaining provisions will continue to apply to the fullest extent permitted by law.

ARTICLE 15. LANGUAGE

15.1 This Policy has been drafted in English.

15.2 Maralvion may make translations or local-language versions of this Policy available through the Website, Website functionality, customer support, translation functionality or other communication channels for user convenience, market access, customer information or compliance support.

15.3 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 this Policy.

15.4 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.

15.5 Articles 15.2 to 15.4 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.

15.6 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 16. GOVERNING LAW, DISPUTE RESOLUTION AND CONTACT

16.1 This Policy and Replacement Requests handled under it are governed by the laws of Poland, without prejudice to mandatory consumer protection provisions that apply in the country in which the Consumer has their habitual residence.

16.2 A Consumer may bring proceedings against Maralvion before the courts permitted under applicable EU and national consumer jurisdiction rules. Maralvion may bring proceedings against a Consumer only before the courts permitted under those rules.

16.3 Maralvion aims to resolve Replacement Requests, complaints and related disputes through Customer Support before further escalation. Customers and Users are encouraged to provide Maralvion with a reasonable opportunity to investigate the matter and propose an appropriate solution.

16.4 Where an applicable national alternative dispute resolution body is available and competent, a Consumer may have the option to submit an unresolved contractual dispute to that body. Maralvion will provide information concerning applicable alternative dispute resolution options where required by law. This Policy does not impose mandatory arbitration on Consumers.

16.5 Replacement Requests and related questions should be submitted to:

GlucoSensor Customer Support
Email: support@glucosensor.com
Website: www.glucosensor.com/support

16.6 A Replacement Request should be submitted through an official GlucoSensor support channel. A communication sent only to the Manufacturer, the Authorised Representative, a carrier, warehouse, fulfilment provider, payment provider, independent seller or another third party does not by itself constitute submission of a Replacement Request to Maralvion unless Maralvion actually receives or expressly acknowledges that communication, or mandatory applicable law provides otherwise.

16.7 Formal notices concerning a Replacement Request, statutory claim or related legal matter may be sent to:

Maralvion sp. z o.o.
Pl. Władysława Andersa 3
11th Floor
61-894 Poznań
Poland
KRS: 0001235440
Email: support@glucosensor.com

Contacting Customer Support does not replace a legally required formal notice, prescribed form or mandatory reporting procedure where applicable law requires a specific method or recipient.

16.8 Sensors, applicators, packaging or other materials must be returned only to the return address expressly confirmed by Customer Support. They must not be sent to Maralvion’s registered office, the Manufacturer, the Authorised Representative or an Authorised Service Provider unless Maralvion expressly instructs the Customer or User to do so.

16.9 The registered office and other postal addresses stated in this Policy, 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.