Medical Device News EU – Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices

[nancy]

To meet the new EU Medical Device Regulation objective, organisations will need to take a structured and well-managed approach over the next coming years depending on the product portfolio.

 

[davids]

No, self-declared medical devices have to comply with the MDR in the date of application (May 2020). Only class I M or S device (which have a valid certificate) may continue to be put into the market under the MDD.

I understand that Article 120 paragraph 4 states that self-declared medical devices (class I) can't be placed on the market after 26 may 2020. Could you elaborate on wether these self-declared class I medical devices can still be made available on the market/put into service?

 

[Shawna]

After May 2020, self declared device need to comply with the regulation requirements of MDR in order to be placed on the market, except the class I device in S or M category

I understand that Article 120 paragraph 4 states that self-declared medical devices (class I) can't be placed on the market after 26 may 2020. Could you elaborate on wether these self-declared class I medical devices can still be made available on the market/put into service?

 

[Ronen E]

Could you elaborate on wether these self-declared class I medical devices can still be made available on the market/put into service?

Yes, provided that they've already been placed on the market by 26 May 2020.