EU MDR · Medium · 12 min lesson
Building each section - GSPR checklist, risk file link, V&V summaries, labelling and the PMS plan
Regulation (EU) 2017/745 Annex I, Annex II sections 2 to 6, Annex III, Articles 84 to 86; ISO 14971:2019; Team-NB guidance
What you will learn
- Build a GSPR checklist in which every line states applicability, method, standard edition and an exact evidence pointer.
- Link the risk management file, verification and validation summaries and labelling so that each risk control is traceable to a test and to the information supplied.
- Write a PMS plan that feeds the file, and tell a weak record from a compliant one.
Key takeaways
- A GSPR line is complete only with applicability or rationale, method, standard and edition, and a pointer to document, revision and section.
- Annex I section 3, 4 and 8 and ISO 14971:2019 connect hazards, controls and the benefit-risk conclusion; acceptability is not justified by a risk number alone.
- Each verification or validation summary names its requirement, risk control, protocol, acceptance criteria, result and deviations.
- Labelling and instructions (Annex I Chapter III, GSPR 23) must carry the residual risks, warnings and UDI that the risk file says they carry.
- The PMS plan under Article 84 and Annex III defines data sources, indicators, thresholds and the feedback to risk, clinical evaluation and labelling.
Free practice question
A GSPR line for the requirement on electronic programmable systems and software reads 'Applies. IEC 62304 followed. See software file.' The software file holds 140 documents.
What is wrong with this line?
It has no precise pointer or edition, so the reviewer must search 140 documents for the proof.
Correct. Annex II section 4 expects document, revision and section pointers, which Team-NB guidance repeats.
Nothing, since the software file is controlled.
Not quite. Control of the file does not replace a precise pointer to the evidence under Annex II section 4.
It should say not applicable.
Not quite. Software requirements apply to software devices; claiming otherwise would breach Annex I.
It needs a bigger font.
Not quite. Formatting is not the problem; the line lacks edition and pointer under Annex II section 4.
Key terms
- traceability matrix: A table linking each requirement or GSPR to risks, controls, tests and reports, so every claim has a findable proof.
- risk control: A measure that reduces a risk, verified by a test and, where needed, communicated in labelling (Annex I section 4).
- residual risk: The risk that remains after controls are applied; it is weighed against benefits (Annex I sections 1, 3 and 8).
- PMS plan: The documented plan for proactively collecting and analysing post-market data, required by Article 84 and Annex III.
- PMCF: Continuous process updating the clinical evaluation with post-market clinical data (Annex XIV part B).
- IFU: Instructions supplied with the device; content set by Annex I Chapter III, section 23.
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
- ISO 14971:2019 - Medical devices, application of risk management
- 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.