Conformity assessment procedure
The conformity assessment procedure is the systematic process for evaluating and certifying that a product meets the essential requirements of the applicable EU regulation. It is a mandatory prerequisite for CE marking.
For medical devices (MDR), the following procedural modules are available:
- Annex IX: QMS-based procedure (with documentation assessment by Notified Body from Class IIa)
- Annex X: EU type-examination
- Annex XI: conformity with the type (product testing or QMS-supported)
For PPE (PPE Regulation):
- Category I: self-conformity assessment by manufacturer
- Category II: EU type-examination by Notified Body (Annex V PPE Reg.)
- Category III: EU type-examination + ongoing quality assurance (Annex VII or VIII PPE Reg.)
Core elements of any conformity assessment procedure:
1. Draw up technical documentation (design, materials, test results)
2. Risk analysis (EN ISO 14971 for medical devices)
3. Clinical evaluation / performance evaluation (depending on product)
4. Involvement of Notified Body (above certain classes)
5. Issue EU Declaration of Conformity
6. Affix CE marking
Frequently asked questions
What conformity assessment modules are available for medical devices?
MDR offers Annex IX (QMS), Annex X (EU type-examination), and Annex XI (product conformity). The choice depends on device class and preferred approach. Annex IX is the most common route for Class IIa and above.
What is the difference between the conformity assessment procedure and the EU Declaration of Conformity?
The conformity assessment procedure is the entire process (technical documentation, risk assessment, Notified Body etc.). The EU Declaration of Conformity is the concluding document the manufacturer issues after successfully completing the procedure.
Must the conformity assessment procedure be repeated?
For substantial modifications to the product or upon expiry of a type-examination certificate, the procedure must be fully or partially repeated. Ongoing post-market surveillance may also trigger reassessments.