Certifying a medical wearable: where to start
A wearable with a medical purpose (a watch that detects an arrhythmia, a patch that monitors a vital sign, a connected blood-pressure cuff) is at once a medical device, medical electrical equipment, software, radio equipment and a battery product. This page maps those regimes as the texts state them on October 7, 2026: which MDR rule sets the class, which standards are actually cited in the Official Journal, where the RED and the Cyber Resilience Act step aside for the MDR and where they do not, what section 524B of the FD&C Act really covers, and what the Battery Regulation asks of a device worn on the body.
The first question: medical device or wellness?
Section titled “The first question: medical device or wellness?”The boundary is drawn by the intended purpose, not by the sensor. Two physically identical watches can fall under different regimes depending on what the manufacturer says about them.
- EU. Article 2(1) of MDR (EU) 2017/745 defines a medical device by its medical purposes, among them "diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease". Article 2(12) defines the intended purpose from "the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation". Article 7 prohibits claims that ascribe functions the device does not have or suggest uses outside the assessed intended purpose.
- US. Section 520(o)(1)(B) of the FD&C Act removes from the device definition a software function "for maintaining or encouraging a healthy lifestyle" that is "unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition". The FDA guidance "General Wellness: Policy for Low Risk Devices" (final version announced on July 29, 2016) sets out how FDA treats low-risk wellness products.
- Guidance. MDCG 2019-11 rev.1 (June 2025) covers qualification and classification of software, MDCG 2023-4 (October 2023) software working with hardware, and the Manual on borderline and classification v5 (April 2026) lists borderline cases.
| Claim | Likely status | What still applies |
|---|---|---|
| Counts steps, estimates calories, tracks sleep | Wellness, outside the MDR | RED including Article 3(3)(e) for wearables (Regulation 2022/30), CRA Annex III class I if it has a health monitoring purpose, Battery Regulation |
| Displays a heart rate "for information" | Borderline, decided by the wording of label, instructions and marketing | Document the qualification against MDCG 2019-11 rev.1 |
| Detects atrial fibrillation and alerts the user | Medical device | MDR, class at least IIa under rule 10 or rule 11, notified body |
| Provides values used to decide a drug dose | Medical device | Rule 11: IIb or III depending on the impact of the decision |
MDR classification drives everything else
Section titled “MDR classification drives everything else”The class sets the conformity assessment route (Article 52) and the depth of the notified-body review. For a wearable, two rules of Annex VIII usually decide, and section 3.5 of that Annex says that where several rules apply "the strictest rule and sub-rule resulting in the higher classification shall apply". Section 3.3 adds that software which drives a device or influences its use falls in the same class as the device.
| Rule (Annex VIII) | Text | Class |
|---|---|---|
| Rule 10 | Active devices intended to allow direct diagnosis or monitoring of vital physiological processes | IIa |
| Rule 10 | Specifically intended for monitoring vital physiological parameters whose variations could result in immediate danger (cardiac performance, respiration, central nervous system activity) | IIb |
| Rule 11 | Software providing information used to take diagnostic or therapeutic decisions | IIa |
| Rule 11 | Same, where the decision may cause a serious deterioration of health or a surgical intervention | IIb |
| Rule 11 | Same, where the decision may cause death or an irreversible deterioration of health | III |
| Rule 11 | Software intended to monitor physiological processes | IIa, or IIb for vital parameters with immediate danger |
| Rule 11 | All other software | I |
| Rule 13 | All other active devices | I |
MDCG 2021-24 rev.1 (April 2026) is the classification guidance. The route that follows from the class:
| Class | Route under Article 52 | Notified body |
|---|---|---|
| I (no sterile, measuring or reusable surgical function) | EU declaration of conformity after the technical documentation of Annexes II and III (Article 52(7)) | No |
| I with measuring function (Im) | Same, plus Annex IX or XI limited to metrological aspects | Yes, limited |
| IIa | Annex IX chapters I and III with technical documentation assessment of at least one representative device per category, or Annexes II and III with Annex XI (Article 52(6)) | Yes |
| IIb (non-implantable) | Annex IX chapters I and III with technical documentation assessment of at least one representative device per generic device group, or Annex X with Annex XI (Article 52(4)) | Yes |
Clinical evaluation follows Article 61 and Annex XIV for every class. The MDR guide covers qualification and the full set of 22 rules, and the MDR class IIb and III deep dive covers the higher-class routes, EUDAMED and the legacy deadlines.
Which standards are actually cited
Section titled “Which standards are actually cited”Article 8 of the MDR gives presumption of conformity only to harmonised standards whose references are listed in the annex to Implementing Decision (EU) 2021/1182. Many standards that a wearable file relies on are not in that list. They remain the normal way to show the state of the art, but without presumption.
| Building block | Standard | Cited under the MDR on October 7, 2026 |
|---|---|---|
| Electrical safety | IEC 60601-1 | Yes, but only EN 60601-1:2006 with A13:2024 (entry 65, Decision (EU) 2026/1231, OJ June 17, 2026) |
| EMC | IEC 60601-1-2 | No |
| Usability | IEC 60601-1-6 with IEC 62366-1 | No |
| Home use | IEC 60601-1-11 (home healthcare environment) | No |
| Software life cycle | IEC 62304 (safety classes A, B, C) | No |
| Risk management | ISO 14971 | Yes, EN ISO 14971:2019 with A11:2021 (entry 16) |
| Quality system | ISO 13485 | Yes, EN ISO 13485:2016 with AC:2018 and A11:2021 (entry 10) |
| Biological evaluation | ISO 10993-1 | Yes, EN ISO 10993-1:2025 (entry 54) |
| Cytotoxicity | ISO 10993-5 | Yes, EN ISO 10993-5:2009 with A11:2025 (entry 55) |
| Skin sensitisation | ISO 10993-10 | Yes, EN ISO 10993-10:2023 (entry 17) |
| Irritation | ISO 10993-23 | Yes, EN ISO 10993-23:2021, with A1:2025 in entry 1a |
The IEC 60601-1 guide details the editions, the collaterals and FDA recognition, and the risk management guide covers ISO 14971. For the quality system, including the US QMSR that has incorporated ISO 13485:2016 into 21 CFR Part 820 since February 2, 2026, see the quality management systems guide.
The radio layer, distinct from the medical regime
Section titled “The radio layer, distinct from the medical regime”A medical device with a radio transmitter remains radio equipment. The MDR does not absorb the RED; only the cybersecurity part of the RED steps aside.
| Requirement | Medical wearable (MDR applies) | Wellness wearable (MDR does not apply) |
|---|---|---|
| RED (EU) 2014/53 Article 3(1)(a) safety and health, RF exposure | Applies | Applies |
| RED Article 3(1)(b) EMC | Applies | Applies |
| RED Article 3(2) spectrum, EN 300 328 at 2.4 GHz | Applies | Applies |
| RED Article 3(3)(d)(e)(f), Regulation 2022/30 | Not applicable (Article 2(1) of 2022/30) | Article 3(3)(e) applies to body-worn equipment that processes personal data, even without internet (Article 1(2)(d)); 3(3)(d) and (f) if internet-connected |
| CRA (EU) 2024/2847 | Not applicable (Article 2(2)(a)) | Important product, class I (Annex III, item 19: personal wearables with a health monitoring purpose) |
Regulation 2022/30 has applied since August 1, 2025 and is repealed from December 11, 2027 by Delegated Regulation (EU) 2026/339, when the CRA takes over; CRA reporting obligations apply from September 11, 2026. The BLE wearable guide works through these layers for a consumer device, and the CRA guide sets out its scope.
In the US, a Bluetooth transmitter is certified under FCC Part 15 and receives an FCC ID; see the FCC ID, grantee and TCB guide and the RED checklist.
RF exposure
Section titled “RF exposure”A device worn on the body is assessed for RF exposure. In the EU, EN 50566 (hand-held and body-mounted devices) is the cited standard under RED Article 3(1)(a), against the limits of Council Recommendation 1999/519/EC. The measurement method is IEC/IEEE 62209-1528, which replaced IEC 62209-1 and IEC 62209-2 in 2020. In the US, portable devices fall under 47 CFR 2.1093, with test exclusion thresholds in KDB 447498. See the SAR procedures guide.
Bluetooth SIG qualification
Section titled “Bluetooth SIG qualification”Use of the Bluetooth trademark requires qualification with the Bluetooth SIG. It is a licensing and interoperability step, not a market authorisation. Since July 1, 2024 new designs receive a Design Number, QDID being the legacy identifier. See the Bluetooth SIG qualification guide.
Cybersecurity: MDR, CRA and section 524B
Section titled “Cybersecurity: MDR, CRA and section 524B”EU. Annex I section 17.2 of the MDR requires software to be developed "in accordance with the state of the art taking into account the principles of development life cycle, risk management, including information security, verification and validation". Section 17.4 requires the manufacturer to set out minimum requirements on hardware, IT network characteristics and IT security measures, "including protection against unauthorised access". MDCG 2019-16 rev.1 (July 2020) is the guidance. Recital 25 of the CRA explains why MDR devices are left out: the MDR already addresses these risks.
US. Section 524B of the FD&C Act was enacted on December 29, 2022 (Pub. L. 117-328, section 3305) and took effect 90 days later, on March 29, 2023. It does not apply to every connected device. It applies to a cyber device, which section 524B(c) defines as a device that:
- includes software validated, installed or authorized by the sponsor as a device or in a device;
- has the ability to connect to the internet; and
- contains any such technological characteristics that could be vulnerable to cybersecurity threats.
For such a device, a 510(k), De Novo or PMA must include a plan to monitor and address post-market vulnerabilities, including coordinated vulnerability disclosure, processes that provide reasonable assurance that the device is cybersecure with updates and patches, and a software bill of materials (section 524B(b)). The FDA guidance "Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions" was reissued on February 3, 2026 to align with the QMSR. The FDA 510(k), De Novo and PMA guide covers the routes, user fees and review clocks.
The battery, an independent regime
Section titled “The battery, an independent regime”The lithium-ion pack of a wearable is usually tested to IEC 62133-2 and qualified to UN 38.3 before transport. For the EU market, Battery Regulation (EU) 2023/1542 applies whatever the medical status:
| Obligation | Date | Note for a wearable |
|---|---|---|
| Separate collection symbol | August 18, 2025 | Applies |
| End-user removability and replaceability (Article 11(1)) | February 18, 2027 | "Readily removable" means with commercially available tools, without proprietary tools, thermal energy or solvents |
| Derogation for medical devices (Article 11(2)(b)) | February 18, 2027 | Covers only professional medical imaging, radiotherapy and IVD devices, not wearables |
| Derogation for continuity of power or data integrity (Article 11(3)) | February 18, 2027 | The route a wearable would have to justify |
| Recycled content (Article 8) | From August 18, 2028 at the earliest | Industrial batteries above 2 kWh, EV, SLI and later LMT batteries; not portable batteries |
See the battery safety and transport guide and the EU Battery Regulation guide.
Dated milestones for a medical wearable
Section titled “Dated milestones for a medical wearable”| Date | Text | Effect |
|---|---|---|
| March 29, 2023 | FD&C Act section 524B | Cyber device content required in US premarket submissions |
| August 1, 2025 | Regulation 2022/30 | RED cybersecurity requirements apply, except to MDR devices |
| August 18, 2025 | Regulation 2023/1542 | Separate collection symbol on batteries |
| February 2, 2026 | QMSR (21 CFR Part 820) | ISO 13485:2016 incorporated by reference in the US |
| May 28, 2026 | Decision (EU) 2025/2371 | Four EUDAMED modules mandatory: actors, UDI and devices, notified bodies and certificates, market surveillance |
| June 17, 2026 | Decision (EU) 2026/1231 | EN 60601-1:2006 with A13:2024 cited under the MDR |
| September 11, 2026 | CRA | Reporting obligations apply (products outside the MDR) |
| February 18, 2027 | Regulation 2023/1542, Article 11 | User-removable portable batteries |
| December 11, 2027 | CRA | Full application; Regulation 2022/30 repealed |
| December 31, 2027 | MDR Article 120(3a) | Last date for legacy class III and class IIb implantable devices (outside the well-established list) |
| December 31, 2028 | MDR Article 120(3a) | Last date for other legacy classes, including IIa and non-implantable IIb |
The legacy dates only matter for a wearable already certified under Directive 93/42/EEC that meets the conditions of Article 120(3c).
The compliance checklist, overview
Section titled “The compliance checklist, overview”- Write down the intended purpose and align label, instructions for use and marketing with it (Articles 2(12) and 7).
- Classify under Annex VIII, rules 10 and 11 first, and record the reasoning against MDCG 2019-11 rev.1 and MDCG 2021-24 rev.1.
- Set up the ISO 13485 quality system and ISO 14971 risk management; under the QMSR the same applies for the US.
- Frame the IEC 62304 software life cycle and safety class.
- Plan IEC 60601-1 testing with the applicable collaterals (60601-1-2, 60601-1-6, 60601-1-11) and IEC 62366-1 usability.
- Run the ISO 10993 biological evaluation of skin-contact materials.
- Freeze the radio hardware, then run RED (Article 3(1) and 3(2)), FCC Part 15 and the RF exposure assessment.
- Engage Bluetooth SIG qualification if the trademark is used.
- Handle the battery: IEC 62133-2, UN 38.3, Battery Regulation labelling and Article 11.
- Build the cybersecurity file: MDR Annex I 17.2 and 17.4 with MDCG 2019-16 rev.1; section 524B if the device is a cyber device.
- Compile the technical documentation of Annexes II and III, then the notified-body assessment (EU) and the 510(k) or De Novo submission (US).
- Register actors, devices and certificates in EUDAMED.
| Market | Final document | Regime |
|---|---|---|
| European Union | EU declaration of conformity and CE marking with the notified body number (class IIa and above) | MDR, RED, Battery Regulation |
| United States | 510(k) clearance or De Novo grant, FCC ID | FD&C Act, 21 CFR Part 807 or 860, FCC Part 15 |
| Trademark | Bluetooth Design Number listing | Bluetooth SIG |
The EU declaration of conformity guide and the technical documentation file contents guide close the documentary loop.
Claims the texts contradict
Section titled “Claims the texts contradict”| Common claim | What the text says |
|---|---|
| "Section 524B applies to connected devices." (this page said so) | It applies to a cyber device: sponsor-validated software, ability to connect to the internet, and characteristics vulnerable to cybersecurity threats (section 524B(c)). |
| "IEC 60601-1-2, IEC 60601-1-6, IEC 62304 and IEC 62366-1 are harmonised standards under the MDR." (this page implied so) | None of them is listed in Decision 2021/1182 as consolidated on June 17, 2026. EN 60601-1 is cited only as EN 60601-1:2006 with A13:2024. |
| "Class IIb means a design dossier examination." (this page said so) | "Design dossier" is a Directive 93/42/EEC term. Article 52(4) of the MDR requires an assessment of the technical documentation of at least one representative device per generic device group. |
| "The Battery Regulation imposes recycled content on the wearable battery." (this page said so) | Article 8 covers industrial batteries above 2 kWh, EV and SLI batteries, and LMT batteries later. Portable batteries are not in it. |
| "Medical devices are exempt from the battery removability rule." | Article 11(2)(b) names only professional medical imaging, radiotherapy and IVD devices. |
| "MDR CE marking is a declaratory regime." (this page said so) | Self-declaration is limited to class I without sterile, measuring or reusable surgical function (Article 52(7)). Class IIa and above require a notified body. |
| "A wellness wearable only has radio and battery obligations." (this page implied so) | Regulation 2022/30 applies RED Article 3(3)(e) to body-worn equipment that processes personal data, and the CRA lists health-monitoring wearables outside the MDR as class I important products. |
| "SAR is measured to IEC 62209." (this page said so) | IEC 62209-1 and -2 were replaced in 2020 by IEC/IEEE 62209-1528; EN 50566 is the standard cited under the RED for body-mounted devices. |
| "The Bluetooth listing gives a Qualified Design ID." (this page said so) | Since July 1, 2024 new designs receive a Design Number. |
| "Medical devices fall outside the RED." | The RED applies; Regulation 2022/30 only lifts Article 3(3)(d)(e)(f) for MDR devices (Article 2(1)). |
Common pitfalls
Section titled “Common pitfalls”| Pitfall | Consequence | Countermeasure |
|---|---|---|
| Medical claim in the marketing of a product designed as wellness | The product becomes a medical device without conformity assessment (Articles 2(12) and 7) | Align design, instructions and marketing from the start |
| Classifying under rule 11 only and ignoring rule 10 | Class set too low for vital-parameter monitoring | Apply section 3.5: the strictest rule wins |
| Claiming presumption of conformity from a collateral standard | Gap found at notified-body review | Cite the exact OJ reference, justify the rest as state of the art |
| Believing Bluetooth SIG qualification equals regulatory compliance | Product non-compliant with RED or FCC | Treat trademark, spectrum and RF exposure separately |
| Assuming the CRA replaces the MDR cyber requirements | Incomplete cyber file | Apply Annex I 17.2 and 17.4 with MDCG 2019-16 rev.1 |
| Glued battery in a product placed on the EU market from February 18, 2027 | Non-compliance with Article 11 | Design for removal or document the Article 11(3) case |
Further reading
Section titled “Further reading”- MDR (EU) 2017/745, medical devices
- MDR class IIb and III deep dive
- IEC 60601-1, medical electrical safety
- ISO 14971 risk management
- FDA 510(k), De Novo and PMA
- SAR procedures IEC 62209 and EN 50360
- BLE wearable certification
- Where to start with certification
Sources and references
Section titled “Sources and references”Sources & references
- Regulation (EU) 2017/745 on medical devices (MDR), Articles 2, 7, 52, 120 and Annexes I and VIII, EUR-Lex eur-lex.europa.eu/eli/reg/2017/745/oj
- Implementing Decision (EU) 2021/1182, harmonised standards under the MDR, consolidated text of 17 June 2026, EUR-Lex eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02021D1182-20260617
- Implementing Decision (EU) 2026/1231, entry 65 (EN 60601-1:2006 with A13:2024), EUR-Lex data.europa.eu/eli/dec_impl/2026/1231/oj
- Decision (EU) 2025/2371, functionality of four EUDAMED electronic systems, EUR-Lex eur-lex.europa.eu/eli/dec/2025/2371/oj
- MDCG endorsed guidance (2019-11 rev.1, 2019-16 rev.1, 2021-24 rev.1, 2023-4), European Commission health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
- IEC 60601-1, medical electrical equipment, general requirements for basic safety and essential performance, IEC webstore.iec.ch/publication/67497
- IEC 62304, medical device software, software life cycle processes, IEC webstore.iec.ch/publication/22794
- ISO 14971:2019, application of risk management to medical devices, ISO www.iso.org/standard/72704.html
- Directive 2014/53/EU on radio equipment (RED), EUR-Lex eur-lex.europa.eu/eli/dir/2014/53/oj
- Delegated Regulation (EU) 2022/30, Articles 1 and 2 (RED Article 3(3)(d)(e)(f)), EUR-Lex eur-lex.europa.eu/eli/reg_del/2022/30/oj
- Regulation (EU) 2024/2847, Cyber Resilience Act, Article 2(2) and Annex III, EUR-Lex eur-lex.europa.eu/eli/reg/2024/2847/oj
- Regulation (EU) 2023/1542 on batteries, Articles 8 and 11, EUR-Lex eur-lex.europa.eu/eli/reg/2023/1542/oj
- 21 U.S.C. 360n-2 (FD&C Act section 524B, ensuring cybersecurity of devices), Cornell Legal Information Institute (US Code) www.law.cornell.edu/uscode/text/21/360n-2
- 21 U.S.C. 360j(o) (FD&C Act section 520(o), software functions excluded from the device definition), Cornell Legal Information Institute (US Code) www.law.cornell.edu/uscode/text/21/360j
- Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions (3 February 2026), U.S. Food and Drug Administration www.fda.gov/media/119933/download
- General Wellness: Policy for Low Risk Devices, notice of availability (Federal Register, 29 July 2016), Federal Register www.federalregister.gov/d/2016-17902
- FDA, Premarket Notification 510(k), FDA www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k
Frequently asked questions
- Is my connected wristband a medical device or a wellness product?
- The intended purpose decides, not the sensor. Article 2(12) of the MDR defines it from the label, the instructions for use, promotional or sales materials and the clinical evaluation. If you claim diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease (Article 2(1)), the product is a medical device under Regulation (EU) 2017/745. In the US, section 520(o)(1)(B) of the FD&C Act excludes from the device definition a software function intended for maintaining or encouraging a healthy lifestyle and unrelated to disease. A wellness wearable is not unregulated in the EU: the RED, the Cyber Resilience Act and the Battery Regulation still apply.
- Which MDR class applies to a medical wearable?
- Two rules of Annex VIII usually decide. Rule 10 puts active devices that allow direct diagnosis or monitoring of vital physiological processes in class IIa, and in class IIb when they monitor vital parameters whose variations could result in immediate danger (cardiac performance, respiration, central nervous system activity). Rule 11 puts software that informs diagnostic or therapeutic decisions in class IIa, IIb if the decision may cause a serious deterioration of health, and III if it may cause death or an irreversible deterioration. Where several rules apply, the strictest one wins (Annex VIII, section 3.5).
- Do I need IEC 60601-1 for a battery-powered worn device?
- If the wearable is medical electrical equipment, IEC 60601-1 is the reference for basic safety and essential performance, and internal battery power does not take it out of scope. Under the MDR, only EN 60601-1:2006 with A13:2024 has been a cited harmonised standard since June 17, 2026 (Decision (EU) 2026/1231). The collateral standards IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability) and IEC 60601-1-11 (home healthcare environment) are not cited under the MDR, so they demonstrate the state of the art without presumption of conformity.
- What is the difference between medical CE marking and FDA 510(k)?
- Under Article 52 of the MDR, only class I devices without a sterile, measuring or reusable surgical function are self-declared. Class IIa and IIb devices go through a notified body (Annex IX chapters I and III with technical documentation assessment, or Annex XI for class IIa). The US 510(k) is a premarket notification showing substantial equivalence to a legally marketed predicate device; with no predicate, De Novo applies. The two regimes are independent and a device sold in both markets satisfies both.
- Which radio rules apply to the Bluetooth link of a medical wearable?
- The RED applies in full to the essential requirements of Article 3(1) and 3(2): safety including RF exposure, EMC and spectrum (EN 300 328 at 2.4 GHz). Delegated Regulation (EU) 2022/30 does not apply Article 3(3)(d)(e)(f) to devices covered by the MDR (Article 2(1)). In the US, the transmitter needs an FCC ID under Part 15, plus an RF exposure assessment under 47 CFR 2.1093. Bluetooth SIG qualification is a separate trademark licence; since July 1, 2024 new designs receive a Design Number.
- Does cybersecurity apply, and under which regime?
- In the EU, MDR Annex I sections 17.2 and 17.4 require software developed with information security in mind and minimum IT security requirements; MDCG 2019-16 rev.1 (July 2020) is the guidance. The CRA does not apply to products covered by the MDR (Article 2(2)(a)), but a health-monitoring wearable outside the MDR is a CRA important product of class I (Annex III, item 19). In the US, section 524B of the FD&C Act applies to a cyber device: sponsor-validated software, ability to connect to the internet, and characteristics that could be vulnerable to cybersecurity threats.
- Does the battery need separate certification?
- The lithium-ion pack is usually tested to IEC 62133-2 and must pass UN 38.3 before air, sea, road or rail transport. In the EU, Regulation (EU) 2023/1542 adds the separate collection symbol (since August 18, 2025) and, from February 18, 2027, end-user removability of portable batteries (Article 11). The Article 11 derogation for medical devices covers only professional medical imaging, radiotherapy and IVD devices, so a wearable relies on the continuity of power case or is designed for removal.
- In what order should these certifications be tackled?
- Freeze the intended purpose first, then classify under Annex VIII, because the class sets the conformity route. Run ISO 14971 risk management, the ISO 13485 quality system and the IEC 62304 software life cycle from the start. Test to IEC 60601-1 and its collaterals on a representative prototype; plan radio, RF exposure and battery tests once the hardware is frozen. Compile the technical documentation of Annexes II and III before the notified-body assessment, and register in EUDAMED, whose four first modules have been mandatory since May 28, 2026.