The Medical Devices Regulation (MDR) provides several conformity assessment routes that medical device manufacturers can choose from to demonstrate compliance with the regulation. These routes determine the level of involvement of a notified body in the assessment process. Here are the main 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
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
For Class IIb.
1. Class IIb, Annex VIII Rule 12 devices
Conformity Assessment as per Article 52 Section 4
Annex IX – QMS Chapters I, III and Annex IX Chapter II Technical Documentation Assessed per generic device group
OR
Annex X – Type Examination Coupled with Annex XI – Part A Production Quality Assurance or Annex XI – Part B Production Verification or both
For Clinical Evaluation Consult Procedure Annex IX Sec 5 / Annex X Sec 6
2. Class IIb implantable WET devices
(Well-Established Technologies (WET) – sutures, staples, dental fillings and braces, tooth crowns, screws, wedges, plates, wires, pins, clips & connectors as per Article 52 of MDR.)
Conformity Assessment as per Article 52 Section 4 second subparagraph
Annex IX QMS Chapters I, III and Annex IX Chapter II Technical Documentation Assessed per generic device group
or
Annex X Type Examination Coupled with Annex XI – Part A Production Quality Assurance or Annex XI – Part B Production Verification or both.
3. Class IIb implantable devices (excluding WET)
Conformity Assessment as per Article 52 Section 5
Annex IX QMS Chapters I, III and Annex IX Chapter II Technical Documentation for every device
OR
Annex X Type Examination Coupled with Annex XI – Part A Production Quality Assurance or Annex XI – Part B Production Verification or both.
Conformity Assessment is a process used to demonstrate whether a medical device meets the requirements mentioned in the Regulation or not. There are three annexes, Annex IX, Annex X & Annex XI, in EU MDR mentioned for different conformity assessment routes. The manufacturer has a choice to select the conformity assessment route based on his device characteristics.
After the successful audit, the Notified Body will issue the following certificates, as per the specific conformity assessment route,
EU quality management system certificate and EU technical documentation assessment certificate, as per Annex IX
EU type-examination certificate, as per Annex X
EU quality assurance certificate or EU product verification certificate, as per Annex XI
For Custom made devices,
As per EU MDR , the manufacturer may choose to apply a conformity assessment route for class III custom-made implantable devices, for the assessment of,
Quality Management System as per Chapter I of Annex IX
or
Production Quality Assurance as per Part A of Annex XI