News-Details

Decided: Delay of MDR!

On April 17th, the EU Parliament decided on the delay of the MDR’s introduction for 1 year - until May 26th 2021.

[Translate to Englisch:]

On April 17th, the European Parliament decided on the delay of the Medical Device Regulation (MDR), enacted in 2017, to avoid shortages and delays of market launches of important medical devices during the Corona crisis.

 

 

With this decision, the Parliament follows the EU commission’s suggestion with 693 votes (1 dissenting vote and 2 abstentions).

 

The suggestion has to be approved by the EU countries and published before coming into effect. This is expected until May 26th at the latest.

 

 

 

The new enactment on in-vitro-diagnostics is not affected by the delay, it will come into effect as of May 26th 2020.

 

(Source: European Parliament)

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