MDR delay official as industry calls to push back IVDR

Regulatory NewsRegulatory News | 24 April 2020 |  By 

Editor's note: This article was updated to reflect that the amendment took effect Friday with its publication in the Official Journal of the European Union.

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 delay was made official on Friday with the publication of the amendment in the Official Journal of the European Union.
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 delay, Regulatory Focus 20 April 2020; European Commission proposes to delay MDR by a year due to COVID-19, Regulatory Focus 3 April 2020).
“[Wednesday’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.”
Medical device industry group MedTech Europe welcomed the delay, saying “The amendment will allow the medical device industry to maintain maximum focus on helping healthcare systems to combat COVID-19, and on addressing the pandemic’s impact on the whole healthcare ecosystem.”
The group said the time bought by the delay should be used to add much-needed infrastructure to ensure the functionality of the new system, such as designating notified bodies and developing additional MDR guidance.
MedTech Europe also called for a similar delay for the In Vitro Diagnostic Regulation (IVDR), which is still set to take effect on 26 May 2022. “MedTech Europe strongly believes that the transition timeline needs to be adapted by at least 12 months, both to address today’s reality and to prevent unintended fall out in the future,” the group said, noting that IVDR implementation progress “has come to a total halt” since the COVID-19 outbreak began.
Council of the European Union, European Commission


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