EU MDR · Medium · 13 min lesson
General safety and performance requirements (Annex I) and the conformity assessment routes
Regulation (EU) 2017/745 Annex I, Articles 5, 8, 9, 19, 20 and 52, Annexes II, IV, VIII, IX, X and XI
What you will learn
- Explain how Annex I is organised and apply its risk control order of design, protection and information.
- Build a requirements checklist in which every row has a justification, a method and an evidence reference.
- Link device class to the Article 52 conformity assessment route and spot a route that does not fit.
Key takeaways
- Annex I has three chapters: general requirements, design and manufacture, and information supplied (sections 1 to 9, 10 to 22 and 23).
- Risk control follows the order of safe design, protection measures, then information for safety (Annex I section 4).
- Every checklist row needs applicability with a reason, a method and a reference to evidence with its revision.
- Article 8 gives a presumption of conformity only for the requirements a cited harmonised standard actually covers.
- Classify under Annex VIII first; Article 52 then sets the route, and the declaration (Article 19) and CE mark (Article 20) follow.
Free practice question
Norvik's checklist row for Annex I section 3 reads: 'Risk management: complies.' It has no method and no document reference. The notified body asks how the row was concluded.
What is missing from the row?
A longer sentence that says complies more strongly.
Not quite. Wording does not substitute for proof; Annex II section 4 expects the solutions adopted and the evidence of conformity.
The method used and a reference to the risk management file and its revision.
Correct. Annex I section 3 requires a risk management system and Annex II section 4 expects solutions and evidence to be traceable.
The signature of the sales director.
Not quite. Sales approval has no role in showing conformity with Annex I section 3 of the MDR.
A statement that the requirement is not applicable.
Not quite. Section 3 applies to every device, so declaring it not applicable would contradict Annex I.
Key terms
- GSPR: The general safety and performance requirements of Annex I to Regulation (EU) 2017/745.
- harmonised standard: A European standard cited in the Official Journal that gives a presumption of conformity for the requirements it covers (Article 8).
- common specifications: Requirements adopted by the Commission where standards are missing or insufficient (Article 9).
- conformity assessment: The procedure that shows a device meets the Regulation, with the route depending on class (Article 52).
- notified body: An independent organisation designated to carry out conformity assessment tasks under the MDR.
- declaration of conformity: The manufacturer's EU statement that the device meets the Regulation, with content set by Annex IV (Article 19).
- technical documentation: The file described in Annexes II and III that demonstrates conformity of the device.
- type examination: Annex X procedure in which a notified body examines a representative sample and the documentation.
Official sources
- Regulation (EU) 2017/745 on medical devices (EUR-Lex)
- OpenRegulatory - Checklist: MDR general safety and performance requirements
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.