Out-Law News 2 min. read

EU explores coronavirus delay to medical device reforms

EU law makers will be asked to delay the implementation of new EU medical device regulations by a year in light of the coronavirus crisis, the European Commission confirmed on Wednesday.

The move follows lobbying by representative bodies in the medical technology industry.

Commission spokesman Stefan de Keersmaecker said: "The Commission is working on a proposal to postpone the entry into force of the new Medical Devices Regulation for one year. We are working hard to submit this proposal early April and we call on [the European] Parliament and on [the] Council [of Ministers] to adopt it quickly, as the deadline for entry into force is at the end of May. This will relieve pressure from national authorities and industry and it will allow them to focus fully on urgent priorities related to the coronavirus crisis."

The EU's Medical Devices Regulation (MDR) is due to take effect from 26 May 2020, while the In-Vitro Diagnostic Devices Regulation (IVDR) will take effect from 26 May 2022. Both regulations will directly apply in EU countries and do not need to be implemented into national law.

It appears from what de Keersmaecker said that the Commission will only support a delay in respect of the MDR.

In addition to the moratorium on MDR at European level, BVMed has called for an 'MDR emergency plan' to be prepared at national level in Germany
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