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Resolution timeline for closing NC's and MDR/UDI and EUDAMED

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Guest user Created:   Mar 18, 2021 Last commented:   Mar 19, 2021

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?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Mar 19, 2021
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

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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.

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Mar 18, 2021

Mar 19, 2021