Module 15 2022

5/19/2022

Certification process MDR

Within scope of 2017/745

Article 2

Classification

Article 51, Annex VIII

Conformity assessment route

Article 52

General Safety and Performance Requirements

Article 5, Annex I

Technical documentation

Annex II, III

Conformity assessment process

Annex IX, X, XIA, XIB

Declaration of conformity

Article 19, Annex IV

CE mark

Article 20, Annex V

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© NAMSA 2021

15

Regulation Governance

16

© NAMSA 2021

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