CE marking medical wearables — MDR scope, CRA exclusion and radio requirements

First establish medical intended purpose and classification under the applicable MDR/IVDR regime. Consumer wellness branding or radio connectivity alone does not establish a medical risk class. MDR devices are excluded from CRA; independent non-medical products/components require their own scope assessment.

Device risk-class assessment

Plain Class I uses the applicable Annex II/III technical documentation and self-declaration. Is, Im and Ir require limited-scope NB assessment under the relevant IX/XI provisions. IIa routes include Article 52(6) documentation with permitted NB alternatives, including Annex XI sections 10/18. IIb and III use Annex IX OR Annex X combined with Annex XI, not a mandatory IX+X combination. Confirm device-specific and special-procedure conditions; include NB/certificate in DoC where applicable.

Non-EU manufacturer representative

A manufacturer outside the Union must designate an EU authorised representative under Article 11 before placing relevant devices on the Union market. This is a specific MDR obligation; do not generalise it to every non-EU CE-marked product.

DoC and EUDAMED context

MDR DoC content includes product identification, Basic UDI-DI, risk class, manufacturer and where applicable authorised representative, relevant NB/certificates, legislation and applied specifications, signatory and declaration date. SRN is included where available. Four EUDAMED modules became mandatory from 28 May 2026: Actor, UDI/Devices, Notified Bodies/Certificates and Market Surveillance (the last serves authorities/Commission). Vigilance/PMS remains separately implemented; do not treat an unavailable module as suspension of current incident duties.

Essential requirements and exclusions

Article 3(1)(a) covers health/safety objectives of LVD without its voltage limits; 3(1)(b) covers EMC; 3(2) covers spectrum. RED Article 1(4) excludes standalone LVD application and EMC Article 2 excludes RED radio equipment. Other applicable acts such as RoHS remain separately assessed. Delegated Regulation 2022/30 activates selected 3(3)(d)-(f) requirements from 1 August 2025 after 2023/2444; its Article 2(1) excludes MDR/IVDR devices from those three cybersecurity requirements, not from all RED duties. Regulation 2026/339 repeals 2022/30 from 11 December 2027; RED itself continues.

Scope and exclusions

CRA concerns products with digital elements made available on the EU market whose intended or foreseeable use includes a direct or indirect logical or physical data connection. MDR/IVDR devices and other Article 2 exclusions require separate scope assessment. Assess manufacturer responsibility and the statutory remote-data-processing definition, not cloud dependence alone. Main product requirements apply from 11 December 2027; Article 14 reporting applies from 11 September 2026.

Evidence to keep with the product

Record the intended purpose, responsible economic operator, target market, first placing date and exact hardware/firmware configuration. For each applicable requirement, link the actual test or assessment record, dated standard/specification, scope and reviewer decision. Proposed controls and supplier marketing statements are not evidence that the final configuration has passed an assessment.

Separate an open question from a completed assessment. A report outside the laboratory's relevant scope, a different firmware build or an unverified exemption needs a reasoned decision before it supports a declaration. Keep original evidence and the issued declaration alongside any AI-assisted working draft.

Using Cenitia for this work

Cenitia assists with a limited regulatory catalogue and draft documents. The manufacturer must confirm applicability, actual applied specifications and completed assessment procedures. AI scores are quality signals, not a probability of conformity. Source monitoring raises a review prompt when validated source text changes; it does not automatically verify amendments, update the corpus or monitor every national rule and OJ standard edition. Public QR verification records issuance, not product certification.

Review status

This guide was substantively corrected by Cenitia on 2 October 2026 using the primary references below. It is an editorial summary, not an authoritative legal quotation or an independently signed expert opinion. Product-specific and licensed-standard questions remain subject to a real technical review.

Primary references

• Primary source 1
• Primary source 2
• Primary source 3
• Primary source 4