Group 146-min

The European Commission has recently approved a proposal to extend the time it takes to certify medical devices in order to reduce the risk of shortages.

The proposal extends the transition period for adapting to new rules, as required by the Medical Devices Regulation.

The new deadlines are based on the risk class of the medical device and will ensure that patients continue to have access to medical devices.

It will also allow medical devices that have been placed on the market in accordance with the current legal framework and are still available to remain on the market.

To summarise the new proposal;

  • The European Commission is considering new proposals to extend the timelines for transitioning to the Medical Devices Regulation (MDR).
  • In July 2022 MedTech Europe published a report focusing on the delays in the certification of general medical devices and active implantable medical devices and included a plea for a course correction to avoid the likely scenario of thousands of devices otherwise being excluded from the market. 
  • The Commission has shared a formal proposal to give manufacturers until 2027 or 2028, depending on risk classification, to get their devices designated under MDR.
  • The proposal now moves to the European Parliament and Council for adoption.

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