Europe – MDR delay moves forward as industry calls to push back IVDR

The European Council voted 27-0 on Wednesday to adopt an amendment to delay the application of the Medical Devices Regulation by one year and allow for EU-wide derogations for certain medical devices needed in the response to the coronavirus disease (COVID-19) pandemic.
 
The move comes less than three weeks after the European Commission proposed the delay and just days after the European Parliament passed the Commission’s proposal with minor changes to ensure the delay would apply to class I devices covered under Article 120(3) of the regulation. (RELATED: EU MDR: Parliament overwhelmingly backs one-year delayRegulatory Focus 20 April 2020; European Commission proposes to delay MDR by a year due to COVID-19Regulatory Focus 3 April 2020).
 
“Yesterday’s adoption will allow us all, in this time of crisis, to maintain our focus on the most critical issues and to ensure the continued availability of vitally important medical devices,” said Stella Kyriakides, European commissioner for health and food safety, who thanked the Parliament and Council for the approving the measure in “record time.”…