Isabel Sotrtomayor Created: May 26, 2021 Last commented: May 27, 2021

Symbol MD in the label of Medical Devices Class I (no sterile)

Hello, from today on, to be compliant with the new EU MDR, the production of Medical Devices Class I (non sterille), needs to have the MD symbol in the label? Thank you, Isabel Sottomayor

0 0

Assign topic to the user

Select user

Expert

Kristina Zvonar Brkić May 27, 2021

All class I medical devices according to the MDR, from today, have to be in compliance completely with the MDR Technical requirements (Annex 2 _ Technical documentation). One of those requirements is to have an MD symbol on the label. For details on what needs to be on the label, please see section 23 of Annex 1 – General safety and performance requirements.

For more information, please see:

EU MDR Annex 1 – General safety and performance requirements https://advisera.com/13485academy/mdr/general-requirements/
EU MDR Annex 2 – Technical documentation https://advisera.com/13485academy/mdr/technical-documentation/

Quote

0 1

Comment as guest or Sign in

HTML tags are not allowed

Name *

Email *

I accept the Privacy and Terms

Notify me when someone replies

May 26, 2021

May 27, 2021

Expert Advice Community