EU MDR · Expert · 13 min lesson
Notified body technical file assessment, sampling and responding to deficiencies
Regulation (EU) 2017/745 Article 52 and Annex IX sections 2.2, 2.3, 3.5 and 4; MDCG 2019-13 rev.1
What you will learn
- Explain how a notified body assesses technical documentation under Annex IX section 4 and what it issues at the end.
- Distinguish full assessment from representative sampling for Class IIa, IIb, IIb implantable and Class III devices, using MDCG 2019-13.
- Write a deficiency response that identifies the root cause, corrects the file as a whole and closes the finding.
Key takeaways
- Class III and implantable Class IIb devices get full technical documentation assessment under Annex IX section 4; listed exceptions such as screws are sampled.
- Class IIa and other Class IIb devices are sampled on a representative basis (Annex IX sections 2.3 and 3.5), by category or generic device group, with documented rationale.
- Annex IX section 4 covers examination, clinical review, assessment report, certificate and approval of changes (4.10).
- Keep every file audit-ready, because the notified body chooses the sample and can change it during surveillance.
- A strong deficiency response states root cause, correction, location with version and the scope of the check elsewhere.
Free practice question
Tessara markets Linea drill guides (Class IIa, one category) and Sera retractors (Class IIb, one generic device group). Its regulatory manager says: 'The notified body will only look at the file we choose to give it.'
How should this be corrected?
Correct: the manufacturer chooses the sample.
Not quite. Annex IX section 2.3 has the notified body select devices on a representative basis, with its own documented rationale.
Incorrect: the notified body selects representative devices per category or group and documents why, so every file must be ready.
Correct. Annex IX section 2.3 and MDCG 2019-13 give selection to the notified body, so all files in the groups must be ready.
Correct, because sampling is optional.
Not quite. Annex IX section 2.3 makes assessment on a representative basis part of the conformity assessment.
Incorrect: it will review every file every year.
Not quite. MDCG 2019-13 sets representative sampling rather than annual review of all files under Annex IX section 2.3.
Key terms
- notified body: Independent conformity assessment body designated under the MDR.
- representative sampling: Assessment of technical documentation for selected devices of class IIa and IIb (Annex IX section 2.3).
- generic device group: Grouping used for class IIb sampling, at the fourth level of the EMDN nomenclature (MDCG 2019-13).
- device category: Grouping used for class IIa sampling (MDCG 2019-13).
- EU technical documentation assessment certificate: Certificate issued after assessment under Annex IX section 4.9.
- clinical evaluation assessment report: The notified body report documenting its review of clinical evidence (Annex IX 4.8).
- deficiency: A question or finding raised by the notified body during assessment that requires a documented response.
- root cause: The underlying reason a defect occurred, which a response must address so the problem does not recur.
Official sources
- MDCG 2019-13 rev.1: Guidance on sampling of MDR class IIa/IIb and IVDR class B/C devices for the assessment of the technical documentation
- MDR Annex IX: conformity assessment based on a quality management system and on assessment of technical documentation
- Team-NB Position Paper: Best Practice Guidance for the Submission of Technical Documentation under MDR, version 4
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.