SPRING DISCOUNT
Get 30% off on toolkits, course exams, and books.
Limited-time offer – ends May 26, 2022
Use promo code:
SPRING30

Expert Advice Community

Guest

Issue with self-certification process  for class I product according  to MDR

  Quote
Guest
Guest user Created:   Feb 21, 2022 Last commented:   Feb 23, 2022

Issue with self-certification process  for class I product according  to MDR

I have an  issue with MDR certification for which I would like to get your advice. The issue is regarding to the self-certification process  for a class I product according  to MDR; the manufacturer being part of the EU. Need for an UDI and basic-UDI, notification to the national authority where  the manufacturer is established, declarationof conformity and then ?
0 0

Assign topic to the user

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Feb 22, 2022

After you registered your class I medical device at the local national authority, usually you will receive a solution by which a Class I product can be placed on the market. And that is it. You can sell your products on the EU market. 

The question here is only are you certified according to the ISO 13485:2016. If you are, then at each periodic audit, the auditor will review the technical file of your class I medical device. 

Quote
0 0
Guest
Louis Clauss Feb 23, 2022

Thank you so much, so  you don't need to register with each national authority where you are putting your device on the national Market

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Feb 21, 2022

Feb 23, 2022

Suggested Topics