Conformity assessment route as per MDR

Chapter V section 2 of conformity assessment procedure 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

Reference

REGULATION (EU) 2017/ 745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

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

2 Replies to “Conformity assessment route as per MDR”

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