EU MDR · Medium · 13 min lesson
Clinical evaluation, UDI, EUDAMED and the person responsible for regulatory compliance (Article 15)
Regulation (EU) 2017/745 Articles 15, 27 to 33, 61 and 86, Annexes VI and XIV, Regulation (EU) 2024/1860
What you will learn
- Run and document a clinical evaluation under Article 61 and Annex XIV, and say when clinical investigations or equivalence conditions apply.
- Describe the UDI structure and the current EUDAMED status, and keep identifiers consistent across label, register and declaration.
- Appoint and evidence a person responsible for regulatory compliance under Article 15 and list the tasks that person ensures.
Key takeaways
- Clinical evaluation is a planned cycle: plan, identify, appraise, analyse, report, then update (Article 61, Annex XIV Part A).
- Implantable and Class III devices need clinical investigations unless an Article 61 exception applies; equivalence needs a contract giving access to the other documentation.
- UDI has a Basic UDI-DI, a UDI-DI and a UDI-PI, and the data must agree on the label, in the register and on the declaration (Article 27, Annex VI).
- Four EUDAMED modules have been mandatory since 28 May 2026; legacy devices register by 28 November 2026; check the Commission page for the rest.
- Article 15 requires a qualified responsible person, with evidence on file, defined tasks and no disadvantage for doing the job.
Free practice question
The Arden plate clinical evaluation report says only: 'A literature review was carried out and the plate is safe.' The report lists no search strings, databases, dates or inclusion criteria. The notified body asks how the review can be repeated.
What is the main gap?
The report is too short for a Class IIb device.
Not quite. Length is not the test; Annex XIV Part A requires a methodologically sound and repeatable process.
The search and appraisal method is not documented, so the evaluation cannot be repeated or judged.
Correct. Annex XIV Part A requires a defined, methodologically sound procedure with identified and appraised data.
The report should be written by the distributor.
Not quite. Article 61 places the clinical evaluation duty on the manufacturer, not the distributor.
The report should omit the literature entirely.
Not quite. Annex XIV Part A expects published literature to be identified and appraised as clinical data.
Key terms
- clinical evaluation: A systematic, planned process to assess clinical data and confirm safety and performance (Article 61, Annex XIV Part A).
- PMCF: Post-market clinical follow-up: continuous collection of clinical data on a marketed device (Annex XIV Part B).
- equivalence: Technical, biological and clinical similarity to another device, allowing its data to be used under conditions in Article 61.
- UDI: The unique device identification system of Article 27 and Annex VI Part C.
- Basic UDI-DI: The model-level identifier used in technical documentation, certificates and declarations.
- EUDAMED: The European database on medical devices, introduced module by module (Article 33).
- PRRC: Person responsible for regulatory compliance, required by Article 15.
- SSCP: Summary of safety and clinical performance for implantable and Class III devices (Article 32).
Official sources
- Regulation (EU) 2017/745 on medical devices (EUR-Lex)
- European Commission - EUDAMED overview
- OpenRegulatory - MDCG 2019-7 on the person responsible for regulatory compliance
- Osborne Clarke - EU triggers mandatory EUDAMED use from May 2026
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.