Glossary · EU medical devices: MDR
Conformity assessment (MDR)
Also known as: MDR conformity assessment, Conformity assessment procedure (MDR)
Under the EU Medical Device Regulation (EU) 2017/745, conformity assessment is the process that shows whether a device meets the regulation’s requirements before it is placed on the market. Article 52 sets the procedure per device class, using Annex IX (quality management system and assessment of technical documentation), Annex X (type examination) and Annex XI (production quality assurance or product verification).
- EU
- MDR
In one sentence
MDR conformity assessment (Article 52) shows a device meets the regulation before market entry, via Annexes IX to XI depending on the class.
Example
A class III heart valve manufacturer follows Annex IX: its notified body audits the QMS, assesses the technical documentation and clinical evaluation, and issues an EU technical documentation assessment certificate before the manufacturer signs the declaration of conformity.
How it applies
- Class I: The manufacturer declares conformity on its own after drawing up the technical documentation. For class Is, Im and Ir, a notified body is involved for the aspects of sterility, metrology or reuse only.
- Class IIa, IIb and III: A notified body is involved. Most manufacturers use Annex IX; Annex X type examination combined with Annex XI is an alternative for some classes.
- Depth by class: The higher the class, the more the notified body looks at individual devices: technical documentation is sampled for class IIa and IIb (with exceptions such as class IIb implantables) and assessed per device for class III.
- Outcome: After a positive assessment the manufacturer draws up the EU declaration of conformity and affixes the CE marking, with the notified body’s number where one was involved.
- AI: For AI-based devices that are high-risk under the AI Act, the AI Act requirements are assessed within this procedure from August 2, 2028; there is no separate AI conformity assessment.
- Technical documentation: The procedure relies on the technical documentation, the clinical evaluation and the QMS records; gaps found by the notified body are closed through documented nonconformity responses.
MDR conformity assessment vs. the general concept
Conformity assessment is a general EU product law concept with standard modules. The MDR defines its own procedures in Annexes IX to XI, with stronger clinical requirements and extra consultation procedures for certain high-risk devices; the general modules are not used directly.