EU MDR · Expert · 13 min lesson
Capstone part 2: reviewer report, nonconformities and certification decision
Regulation (EU) 2017/745 Annex IX, Annex VII and Article 56, applied to a fictional Class IIb review
What you will learn
- Write a nonconformity with requirement, evidence, finding and a graded reason.
- Structure the reviewer report and judge a manufacturer response and its effectiveness.
- Reach a certification decision using the options in Article 56 and explain post-certification follow-up.
Key takeaways
- A nonconformity states requirement, evidence and finding in one factual sentence and carries a grade with a reason.
- Grades are set by notified body procedures, not by the regulation; they follow impact and whether the failure is isolated or systemic.
- The reviewer report records scope, method, findings, the clinical evaluation conclusion and a recommendation.
- Article 56: certificates last at most five years, may be restricted, and may be suspended or withdrawn with reasons.
- Closure requires verified evidence that the correction works, and the decision should be independent of the review.
Free practice question
A reviewer writes: 'The clinical evaluation is not good enough.' Norvik asks which document, which requirement and what to fix. The reviewer replies that the manufacturer should know.
What is wrong with this finding?
Nothing: the manufacturer owns the file and should know.
Not quite. A finding must state a requirement and evidence; Annex XIV Part A gives the requirements, so vagueness is a defect.
It lacks a requirement, evidence and a factual statement, so it cannot be acted on.
Correct. A usable finding names the requirement such as Annex XIV Part A, the document and the factual gap.
It is too polite.
Not quite. Tone is not the problem; the absence of requirement and evidence is the problem with this finding, as Annex IX assessment expects.
It should be graded Major automatically.
Not quite. A grade follows impact and extent after the finding is stated, not before; the finding is incomplete first, as Annex IX assessment expects.
Key terms
- nonconformity: A statement that a requirement is not met, backed by evidence from a named record.
- notified body: An organisation designated to carry out conformity assessment under Regulation 2017/745 (Chapter IV).
- Annex IX: The annex describing conformity assessment based on a quality management system and assessment of technical documentation.
- Article 56: The article on certificates of conformity: validity of up to five years, restrictions, suspension and withdrawal.
- clinical evaluation: A planned, continuous process to collect and appraise clinical data for a device (Article 61, Annex XIV Part A).
- containment: Action to deal with devices or records already affected by a nonconformity.
- effectiveness check: Verification that a corrective action works, usually by sampling the same area again.
- PSUR: Periodic safety update report on post-market data for the classes that require it (Article 86).
Official sources
- Regulation (EU) 2017/745 on medical devices (EUR-Lex)
- EU MDR Article 56 certificates of conformity (Advisera summary)
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.