EU MDR · Medium · 12 min lesson
Notified body assessment of the IVDR file, PMPF, the summary of safety and performance and typical deficiencies
Regulation (EU) 2017/746 Articles 29, 48 to 51, 78 to 83, 100, Annex VII, Annex IX, Annex III, Annex XIII Part B
What you will learn
- Explain how a notified body reviews an IVDR file by class and prepare answers that point to controlled evidence.
- Write a specific surveillance plan with follow-up under Annex III and Annex XIII Part B, and tell the PMS report from the periodic safety update report.
- Draft a summary of safety and performance under Article 29 that matches the evaluation report, and find planted gaps across documents.
Key takeaways
- Notified body depth follows class: sampling for B and C, every file for D with reference laboratory and scrutiny steps (Articles 48 to 50, 100).
- Answer questions with controlled evidence: document, revision and section; correct the document and look for the same defect elsewhere.
- The surveillance plan (Article 79, Annex III) needs sources, indicators and thresholds; follow-up (Annex XIII Part B) is planned or justified.
- Class A and B use a PMS report (Article 80); class C and D use a periodic safety update report updated at least annually (Article 81).
- The summary of safety and performance (Article 29) is validated by the notified body and must match the evaluation report; most deficiencies are documents that disagree.
Free practice question
Verano's evaluation report for a class C assay says specificity is only 0.6 percentage points above its criterion. The surveillance plan lists complaints and vigilance only, with no follow-up activity and no justification.
What does Annex XIII Part B expect?
A follow-up activity addressing the narrow margin, or a written justification that none is needed.
Correct. Annex XIII Part B ties follow-up to gaps in the evaluation, or to a justification.
Nothing: a passing result needs no follow-up.
Not quite. Annex XIII Part B expects follow-up to update the evaluation, especially for narrow margins.
Only a complaints log.
Not quite. A complaints log alone is reactive and does not meet proactive follow-up under Annex XIII Part B.
Waiting for the notified body to ask.
Not quite. Annex XIII Part B and Article 79 place the planning duty on the manufacturer.
Key terms
- post-market performance follow-up: A continuous process that updates the performance evaluation, planned under Annex XIII Part B.
- periodic safety update report: The report for class C and D devices, updated at least annually (Article 81).
- post-market surveillance plan: The plan, part of the technical documentation, setting sources, methods and indicators (Article 79, Annex III).
- summary of safety and performance: A public summary for class C and D devices, validated by the notified body and uploaded to Eudamed (Article 29).
- EU reference laboratory: A laboratory designated under Article 100 that can verify performance and batches of certain class D devices.
- clock stop: The pause in a notified body review while the manufacturer prepares answers to questions.
Official sources
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices, consolidated text (EUR-Lex)
- HPRA: IVDR transitional provisions (Regulation (EU) 2024/1860 dates and conditions)
- European Commission: Questions and answers on the extension of the IVDR transitional periods
- Decomplix: PMCF and PMPF practical guide (secondary source)
- MDR Regulatory: IVDR overview (secondary source)
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.