MDR Conformity Assessment Routes

Chapter V section 2 of MDR Conformity Assessment Routes based on article 52.

Conformity assessment route for class I device as per Article 52 of clause 7,

Class I

Annex II and III of Technical Documentation

Class Is/Im/Ir

Annex II and III of Technical Documentation

and Annex IX QMS Chapters I, III

Or

Annex II and III of Technical Documentation

And Annex XI – Part A Production Quality Assurance

Conformity assessment route for class IIa device as per Article 52 of clause 6:  

Class IIa

Annex IX QMS Chapters I, III   and Annex IX Chapter II Technical Documentation

Or

Annex XI – Part A Production Quality Assurance and Annex II and Annex III

Technical Documentation

Or

Annex XI – Part B Production Verification and Annex II and Annex III Technical Documentation

Conformity assessment route for class IIb device as per Article 52 of clause 4 and 5,

Class IIb

Annex IX QMS Chapters I, III   and Annex IX Chapter II Technical Documentation

Or

Annex X type examination and Annex XI product conformity verification

Conformity assessment route for class III device as per Article 52 of clause 3,

Class III

Annex IX QMS Chapters I, III   and Annex IX Chapter II Technical Documentation

Or Annex X type examination and Annex XI product conformity verification

MDR Conformity Assessment Routes 1

Reference

EU Medical Devices Regulation (MDR 2017/745) April 5, 2017.

Myself Neethu Jino, Consultant at I 3 consulting, writing this article to share my experiences. If you need more information please write to me, na@i3cglobal.com