ISO 13485 · Expert · 15 min lesson
Auditing technical documentation (Annex II and III) and clinical evaluation
EU MDR 2017/745 Annexes II and III, Article 61, Annex XIV and Article 10(9) a); ISO 19011 audit practice
What you will learn
- Sample a technical file against Annex II and III.
- Audit the clinical evaluation plan and report.
- Check change control against the technical file.
Key takeaways
- Annex II has six sections; use it as the map and sample across all of them, weighted by risk.
- Follow every index link to the approved, current controlled document and record the revision.
- Annex III requires a device specific PMS plan in the file, with a PMCF plan or a justification.
- Clinical evaluation is a plan, a repeatable literature review, a justified equivalence claim and updates with PMS and PMCF data (Article 61, Annex XIV).
- A change is complete only when the risk file, checklist, verification evidence and information supplied reflect it.
Free practice question
Tessaro's clinical evaluation report CER-03 rev B is dated 2023. The clinical evaluation plan CEP-03 rev A is dated two months after the report. The plan states the methods that the report supposedly followed.
What is the audit conclusion?
The plan was approved after the report, so the evaluation was not planned as Annex XIV Part A requires; the plan cannot have governed the report.
Correct. Annex XIV Part A starts the process with a clinical evaluation plan, so a later plan shows the sequence was reversed.
No finding, because both documents exist.
Not quite. Existence is not enough; Annex XIV Part A describes a planned process in which the plan comes first.
A finding only against the literature search.
Not quite. The search may be sound; the nonconformity is that the plan did not precede the evaluation under Annex XIV Part A.
An observation, since the dates are close.
Not quite. Closeness of dates does not change the sequence that Annex XIV Part A requires for a planned evaluation.
Key terms
- technical documentation: The documentation set described in Annexes II and III that demonstrates conformity of the device.
- clinical evaluation plan: The plan that specifies purpose, clinical benefits, methods and parameters before the evaluation (Annex XIV Part A).
- clinical evaluation report: The report documenting the appraisal and analysis of clinical data and the conclusions on safety, performance and benefit-risk.
- PMCF: A continuous process proactively collecting clinical data on the device in use (Annex XIV Part B).
- equivalence: Demonstrated technical, biological and clinical similarity allowing use of another device's clinical data (Article 61).
- PMS plan: The device specific plan for collecting and assessing post market data, required in Annex III.
- modification management: Assessing and controlling changes, including their effect on the technical documentation (Article 10(9) a)).
- traceability: A documented chain from an index entry to the approved document revision that supports it.
Official sources
- Regulation (EU) 2017/745 on medical devices (MDR), EUR-Lex
- MDCG 2020-13 Clinical evaluation assessment report template
- MDCG 2020-8 Guidance on PMCF evaluation report template
- ISO 19011:2018 Guidelines for auditing management systems
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.