Resolution timeline for closing NC's and MDR/UDI and EUDAMED
1. Hello, Could you advise on defining the resolution timeline for closing Critical, Major and Minor NC ? The product is '' image viewer software ''?
2. Could you advise if the company preparing for MDR transition from MDD needs to register for UDI/ EUDAMED if they will not be placing the product on the EU market?
Assign topic to the user
1. Hello, Could you advise on defining the resolution timeline for closing Critical, Major and Minor NC ? The product is '' image viewer software ''?
Defining both the criteria for determining critical, major, or minor non-conformity and the resolution time for closing non-conformities is your responsibility, according to your risk analysis. For example, if critical non-conformity means the worst one, then resolution time can be 15 days, for major 30 days, and for minor non-conformity 60 days. It is just a suggestion
More information regarding this topic, you can find on the following links:
- What are the consequences of non-compliance with ISO 13485 for manufacturers of medical devices? https://advisera.com/13485academy/blog/2017/11/02/what-are-the-consequences-of-noncompliance-with-iso-13485-for-manufacturers-of-medical-devices/
- How to write a good ISO 9001 audit nonconformity? https://advisera.com/9001academy/blog/2018/04/24/how-to-write-a-good-iso-9001-audit-nonconformity/
2. Could you advise if the company preparing for MDR transition from MDD needs to register for UDI/ EUDAMED if they will not be placing the product on the EU market?
Registration in the EUDAMED database is mandatory for manufacturers, authorized representatives, and importers. Manufacturers mean the business entity who certified their medical device (CE marking) and puts it under their name. So, if you're not placing the product on the EU market, then you do not need to be registered in the EUDAMED and do not need to issue a UDI number.
Comment as guest or Sign in
Mar 19, 2021