EU MDR · Medium · 12 min lesson
IVD-specific content - performance evaluation, stability, traceability, GSPR, common specifications and transitional dates
Regulation (EU) 2017/746 Article 56, Article 110 as amended by Regulation (EU) 2024/1860, Annex I, Annex II sections 4 and 6, Annex XIII Part A, Implementing Regulation (EU) 2022/1107
What you will learn
- Build a performance evaluation from scientific validity, analytical performance and clinical performance under Annex XIII, with a plan first and an assessing report.
- Present stability, calibrator and control traceability and the Annex I GSPR checklist so that the evidence matches the claims.
- Apply common specifications and the current Article 110 transitional dates, and run a gap analysis of a legacy file.
Key takeaways
- Performance evaluation has three pillars: scientific validity, analytical performance and clinical performance (Article 56, Annex XIII Part A).
- The plan comes first with pre-set acceptance criteria; the report assesses all data, favourable and unfavourable.
- Class C and D evaluation reports are updated when necessary and at least annually (Article 56).
- Stability data (Annex II 6.3) and calibrator traceability (Annex I) must match the claims in duration and scope.
- Common specifications are binding unless an equivalent solution is justified; legacy dates run to 2027, 2028 and 2029 by class under Article 110.
Free practice question
Verano's prostate marker report quotes sensitivity and specificity from a handful of favourable samples. No performance evaluation plan exists; the plan was written after the studies and is dated the week of submission.
What does Annex XIII Part A expect that is missing here?
A plan approved before the studies, with acceptance criteria set in advance.
Correct. Annex XIII Part A section 1.1 expects the plan first, and a later date undermines pre-set criteria.
A longer report with more adjectives.
Not quite. Length is not the gap; Annex XIII needs a prior plan and honest assessment.
A colour logo.
Not quite. A logo has nothing to do with Annex XIII evaluation planning. Reviewers test this point against the Regulation text and the controlled records in the file.
Nothing: results are enough.
Not quite. Annex XIII requires a plan and an assessing report, not only results.
Key terms
- scientific validity: The association of an analyte with a clinical condition or physiological state (Annex XIII Part A).
- analytical performance: The ability of a device to correctly detect or measure an analyte, including trueness, precision, sensitivity and specificity.
- clinical performance: The ability of a device to give results correlated with a clinical condition in the intended population by the intended user.
- performance evaluation plan: The plan, written first, setting purpose, methods and acceptance criteria for the evaluation (Annex XIII Part A, section 1.1).
- metrological traceability: The chain linking an assigned calibrator or control value to a higher-order reference, with stated uncertainty.
- common specification: A set of requirements adopted by implementing act where standards are missing or insufficient (Article 9).
- legacy device: A device placed on the market under Directive 98/79 that may continue under Article 110 conditions.
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
- Commission Implementing Regulation (EU) 2022/1107 on common specifications for certain class D IVDs (EUR-Lex)
- NAMSA: IVDR technical documentation, five critical parameters of change
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.