EU MDR · Medium · 12 min lesson
Notified body review of the technical file - sampling, typical deficiencies, change control and keeping it current
Regulation (EU) 2017/745 Article 52, Annex IX Chapter I section 2.3 and section 4, Article 10(4), Article 86; Team-NB guidance
What you will learn
- Explain which technical documentation a notified body assesses for each class and how sampling works under Article 52 and Annex IX.
- Recognise the typical deficiencies reviewers raise and answer them with a root cause fix across the whole file.
- Run change control and periodic review that keep the file current, and find planted gaps in a case.
Key takeaways
- Class III and implantable class IIb devices (except the listed exemptions) have technical documentation assessed for every device; other class IIb and IIa are sampled by generic device group or category.
- Sampling continues after certification: Article 52(14) refers to the sampling plan in Annex IX section 2.3 and to surveillance in section 3.5.
- Recurring deficiencies are inconsistency, GSPR without evidence, N/A without reasons, RPN-only acceptability, drafts, stale clinical data and unassessed legacy evidence.
- A good response fixes the root cause across the file and records what changed, not only the page cited.
- Change control assesses every change against all sections of the file and decides whether the notified body must be informed or approve (Annex IX sections 2.4 and 4.10).
Free practice question
A manufacturer of class IIb non-implantable infusion sets has 12 variants in two technology families. The notified body asks how technical documentation will be sampled.
What does Article 52 provide?
At least one representative device per generic device group is assessed.
Correct. Article 52(4) sets sampling per generic device group for class IIb devices other than implantable ones.
Every one of the 12 variants must be assessed in full.
Not quite. Full assessment of every device applies to class III and implantable class IIb under Article 52, not here.
Only the best-selling variant is assessed.
Not quite. Article 52 uses generic device groups and representativeness of the sampled device, and sales volume plays no role in that choice.
No assessment, because class IIb is low risk.
Not quite. Class IIb devices have technical documentation assessed under Annex IX section 4 in a sampled way.
Key terms
- generic device group: A set of devices with the same or similar intended purposes or technology; for class IIb the notified body assesses at least one representative device per group (Article 52(4)).
- category of devices: A set of devices with the same or similar intended use or common technology; class IIa documentation is sampled per category (Article 52(6)).
- nonconformity report: A formal notified body finding that a requirement is not met, to which the manufacturer must respond with a correction and root cause.
- significant change: A change to design, intended purpose or QMS that must be notified to the notified body under the certificate conditions (Annex IX sections 2.4 and 4.10).
- PSUR: Periodic safety update report (Article 86); a key input for keeping the file current.
- state of the art: The generally acknowledged level of technical and medical knowledge that standards and evidence are checked against (Annex I).
Official sources
- Regulation (EU) 2017/745 (MDR), consolidated text on EUR-Lex
- Team-NB Best Practice Guidance for the submission of technical documentation under MDR Annexes II and III, version 4 (21 April 2026)
- DQS: practical lessons from the Team-NB technical documentation guidance revision
- MDR Article 52 text on conformity assessment procedures (Advisera)
- MDCG 2022-21 - Guidance on periodic safety update reports (Team-NB copy)
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.