Procedure(s) for conformity assessment

The term "Conformity assessment" means the process demonstrating whether the requirements of the Medical device regulation EU MDR 2017/745 relating to a medical device have been fulfilled. Medical device manufacturers have to follow conformity assessment procedures before placing products on the market. With conformity assessment procedures manufacturers must prove compliance of the products with the essential requirements laid down in Medical Device Regulation.

However, there is no requirement in MDR that the conformity assessment procedure must be documented. In Article 52 - Conformity assessment procedures states that manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes 9 to 11.

• EU MDR Annex 9 - Conformity assessment based on a quality management system and assessment of the technical documentation
• EU MDR Annex 10 - Conformity assessment based on type examination
• EU MDR Annex 11 – Conformity assessment based on product conformity verification

Here you can find the direct links to the Annexes:

• EU MDR Article 52 – Conformity assessment procedure https://advisera.com/13485academy/mdr/conformity-assessment-procedures/
• EU MDR Annex IX https://advisera.com/13485academy/mdr/conformity-assessment-based-on-a-quality-management-system-and-assessment-of-the-technical-documentation/
• EU MDR Annex 10 https://advisera.com/13485academy/mdr/conformity-assessment-based-on-type-examination/
• EU MDR Annex 11 https://advisera.com/13485academy/mdr/conformity-assessment-based-on-product-conformity-verification/