EU MDR conformity route workflow

Start with a controlled device profile, not a generic compliance checklist. The profile should identify the manufacturer role, intended purpose, users and patient population, configurations, accessories, software, sterile or measuring claims, reusable surgical instrument status, implantable status, medicinal-substance or human/animal-origin material issues, custom-made or investigational status, and whether the product is an Annex XVI product without an intended medical purpose.

This facts pack is the basis for Article 51 classification and for the Annex II technical documentation. If the intended purpose, risk controls, software function, sterilisation claim, or supplied accessory set changes, re-run the route before relying on an old classification memo.

Article 52 sets the conformity assessment routes. Class I devices usually proceed by manufacturer declaration after Annex II and III technical documentation, but sterile class I, measuring class I, and reusable surgical instruments require notified-body involvement limited to the relevant sterile, metrological, or reuse aspects. Class IIa and IIb routes bring notified-body assessment of the QMS and representative technical documentation samples, while higher-risk devices receive deeper technical-documentation review.

For class III devices, the default route is Annex IX; the alternative is Annex X type examination coupled with Annex XI product conformity verification. For class IIb devices, Annex IX Chapters I and III apply with technical-documentation assessment of at least one representative device per generic device group, except certain class IIb implantable devices where every device needs the Annex IX Section 4 technical-documentation assessment. Class IIa devices use Annex IX Chapters I and III with at least one representative device per category, or Annexes II and III with Annex XI Section 10 or 18.

The conformity route is not ready until the evidence pack is route-specific. For Annex IX, the QMS application should include the draft EU declaration of conformity, QMS documentation, procedures for keeping the QMS effective, PMS and PMCF documentation where applicable, vigilance procedures, clinical evaluation planning, and procedures for updating the clinical evaluation plan. The notified body audits the QMS and, for class IIa and IIb, pairs QMS assessment with representative technical-documentation sampling.

Annex II and III evidence should support the route decision rather than sit beside it. The file should connect each applicable GSPR to the selected method of conformity, the harmonised standard or common specification if used, and the precise controlled evidence location. Clinical evaluation, PMCF, PMS, UDI assignment, supplier controls, sterilisation validation, software validation, biocompatibility, shelf-life, and manufacturing controls should be included where they are relevant to the device.

The route closes only when the regulatory outputs match the route. Where the notified body issues a certificate, the certificate should identify the device, intended purpose, risk classification, Basic UDI-DI where required, relevant annex, surveillance conditions, and conformity assessment conclusion. The manufacturer then maintains the EU declaration of conformity under Article 19 and affixes CE marking under Article 20 when the applicable route has demonstrated conformity.

UDI and EUDAMED readiness should not be postponed until artwork release. Article 27 requires UDI assignment and the Basic UDI-DI on the EU declaration of conformity, Article 29 links Basic UDI-DI timing to notified-body applications for some devices, and Article 31 requires the SRN to be used when applying to a notified body and accessing EUDAMED.

A route decision is not permanent. Article 10 requires series-production conformity procedures to account for design, characteristic, harmonised-standard, and common-specification changes. Annex IX requires the manufacturer to inform the notified body of planned substantial QMS or device-range changes, and changes to an approved device can require notified-body approval or a new conformity assessment when safety, performance, or conditions of use are affected.

For legacy devices relying on the 2023/607 transitional framework, the route file should separately document that the device continues to meet the applicable Directive requirements, has no significant change in design or intended purpose, does not present an unacceptable health or safety risk, has the required MDR QMS in place, and has the required notified-body application and written agreement where the transition conditions apply. MDR PMS, market surveillance, vigilance, and registration requirements still apply to those transitional devices under Article 120 as amended.