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12-month MDR delay confirmed by EP

  • Posted by: inetika
  • Category: GLOBAL NEWS

On Friday 17 April 2020, the European Parliament and Council approved the Commission’s proposal to delay the Date of Application (DoA) of the Medical Device Regulation (MDR, 2017/745) by 12 months, to 26 May 2021. The result of the vote in the Parliament was 693 in favour, 1 against, and 2 abstentions.

The next stage is for the proposal to be approved by the member states and for the amending Regulation to be published in the Official Journal before taking effect. According to Parliament, those actions are expected at the latest by May 26, MDR’s original DoA.

The Irish Health Products Regulatory Agency (HPRA) was among the first to announce the result of the vote on its website.

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