25. Mai 2020

Postponement of MDR – opportunities, pitfalls and impact on timelines

 

Now you have the opportunity for MDD submissions, the door has reopened for a moment. This might facilitate your market access. Please find below some answers to the most important questions regarding timelines.

 

How much time do I have to go for MDD?

You can obtain MDD certification or issue a declaration of conformity until 26. May 2021. However, most notified bodies close their doors for MDD requests by September 2020 or even earlier.

 

If my product is on the market under MDD, when will an update to MDR become necessary?

If your certificate expires, or if you make significant changes to your product after 26. May 2021, your product will need to comply with the MDR.

Otherwise your product can be placed on the market until 26. May 2024 and be made available until 27. May 2025.

 

How about EUDAMED?

The actor registration module will become available by March 2021 at the latest. This module will allow for manufacturers to enter their data in Eudamed and to acquire a Single Registration Number (SRN).

The availability of the UDI/Device Registration module is expected by May 2021.

 

What about the MRA (Mutual Recognition Agreements) and the need for an EC-REP (Authorised Representative) for Companies located in Switzerland?

Until May 2021, your product can stay on the market without an EC-REP. However, some notified bodies might request that you have an EC-REP, when they issue a certificate which exceeds this timeframe.

 

Can we help you to bring your medical device to market? Contact us, if you need support.