Article 52 — Conformity Assessment Procedures
Source: EU MDR 2017/745 Article 52 | OJ L 117, 5.5.2017
Conformity Assessment Pathways by Device Class
| Device Class | Conformity Assessment Procedure | Notified Body Involvement |
|---|---|---|
| Class I (non-sterile, non-measuring, non-reusable surgical) | Annex IV — Self-declaration | Not required |
| Class I sterile | Annex IX (QMS, sterility aspects only) or Annex XI (verification, sterility aspects only) | Required |
| Class I measuring function | Annex IX (QMS, measuring aspects only) or Annex XI (verification, measuring aspects only) | Required |
| Class IIa | Annex IX (QMS) or Annex X (type examination) + Annex XI (verification) | Required |
| Class IIb (non-implantable) | Annex IX (QMS) or Annex X (type examination) + Annex XI (verification) | Required |
| Class IIb implantable | Annex IX (QMS) + Annex IX Section 4 (design dossier assessment), or Annex X + Annex XI | Required (incl. design dossier assessment) |
| Class III | Annex IX (QMS) + Annex IX Section 4 (design dossier assessment), or Annex X + Annex XI | Required (incl. design dossier assessment) |
Annex Overview
- Annex IV — EU Declaration of Conformity (Class I self-declaration)
- Annex IX — Conformity assessment based on a quality management system (including production quality assurance)
- Annex X — Type examination
- Annex XI — Production quality assurance (Annex XI Part A) or product verification (Annex XI Part B)
Special Rules
Article 54 — Expert Panel Consultation for Certain Devices
Class III devices and certain Class IIb implantable devices require the notified body to consult an Expert Panel established by the European Commission (under Art.106) before issuing a certificate. This consultation requirement is set out in Art.54.
Article 52.8 — Custom-Made Devices
Manufacturers of custom-made devices shall draw up a statement in accordance with Annex XIII.