Schedule 3 — Conformity assessment
This page covers official UK legislation. Always verify against the current consolidated text at legislation.gov.uk.
This site provides general information only and does not constitute legal or regulatory advice.
Overview
Schedule 3 of the UK MDR 2002 contains the conformity assessment annexes (Annexes I–VII equivalent) for general medical devices. Equivalent provisions for AIMDs are in Part II Schedule 3, and for IVDs in Part III Schedule 3.
Schedule 3 structure
Schedule 3 of Part I contains the following conformity assessment annexes:
| Annex | Procedure | Used for |
|---|---|---|
| Annex I | Quality management system statement | Class I self-declaration |
| Annex II | Full quality system | Class IIa, IIb, III (+ design dossier for Class III) |
| Annex III | EC type-examination (paired with Annex IV, V, or VI) | Class IIa, IIb |
| Annex IV | Production quality assurance | Paired with Annex III |
| Annex V | Product quality assurance | Paired with Annex III |
| Annex VI | Production quality assurance (declaration) | Paired with Annex III |
| Annex VII | EC declaration of conformity (self-declaration) | Class I |
See Conformity assessment overview and Class IIa · IIb · III — UK Approved Body routes for detailed guidance.
Official references
| Reference | Description |
|---|---|
| UK MDR 2002, Schedule 3 | Full conformity assessment procedures |
Note: Annex III (EC type-examination) is always used in combination with one of the following production or product quality assurance annexes:
- Annex IV — Production quality assurance
- Annex V — Product quality assurance
- Annex VI — Production quality assurance (declaration)
A device cannot comply with Annex III alone; the manufacturer must select Annex III paired with one of IV, V, or VI. The choice depends on the level of quality control required for the specific device and risk profile.