MDR - annex XI - article 1-3
Conformity assessment based on product conformity verification
1. The objective of the conformity assessment based on product conformity verification is to ensure that devices conform to the type for which an EU type-examination certificate has been issued, and that they meet the provisions of this Regulation which apply to them.
Based on a EU type-examination certificate, the conformity verification is applicable. During this procedure, it is verified that the type-exmination certificate still conforms with the technical documentation and the process implemented. Further, the overall certification has to conform with the regulation MDR 2017/745.
2. Where an EU type-examination certificate has been issued in accordance with Annex X, the manufacturer may either apply the procedure set out in Part A (production quality assurance) or the procedure set out in Part B (product verification) of this Annex.
For a type-examination certification, the manufacturer can choose which path to follow to verify the conformity.
The manufacturer can choose between the production quality assurance and the product verification.
3. By way of derogation from Sections 1 and 2 above, the procedures in this Annex coupled with the drawing up of technical documentation as set out in Annexes II and III may also be applied by manufacturers of class IIa devices.
Any questions left? Contact Avanti Europe to discuss with an expert