Latest MDCG Preparedness Plan and MDR Delay

The European Commission proposed a delay of the MDR and suggested to postpone the date of application for one year due to the current COVID-19 crisis.

The Joint Implementation/Preparedness Plan on the new EU medical devices regulation (MDR) launched by the Medical Device Coordination Group (MDCG) earlier this month did not fully recognize the challenges the medical device industry is currently facing. This is what may be read and heard in numerous expert rounds these days. 

Although the MDCG acknowledges that Notified Body capacity is challenge, there is was no mentioning of the current COVID-19 crisis with its severe effects on business including travel restrictions and other limitations manufacturers and other operators must currently deal with.

It now appears that the calls for a postponement of the MDR have been heard. In a press conference held on March 25, 2020, the Commission said it works on a proposal to postpone the date of application of the MDR for one year. 

It is not clear yet under what conditions this delay might apply and how far-reaching the consequences are.

It is not clear yet under what conditions this delay might apply and how far-reaching the consequences are. In general, all parties involved are best advised to carefully observe the situation. 

We will keep you informed about any significant developments in this regard.

Source: Medtech Insight (an Informa product)

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