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European Parliament votes to extend MDR transition period

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European Parliament on 16 February 2023 voted overwhelmingly to extend the Medical Devices Regulation (MDR, 2017/745) transition periods to avoid a shortage of life-saving products in the region. The vote also supported eliminating the sell-off date provision for existing products specified in the MDR and In Vitro Diagnostic Medical Devices Regulation (IVDR, 2017/746).

In a 537-3 vote, with 24 abstentions, the European Parliament adopted a proposal by the European Commission to delay the transition period due to concerns about device supply, notified body capacity and manufacturer preparedness. The parliamentarians decided to move forward with the vote without a discussion, due to the urgent nature of the legislation.

The amendment comes after a 6 January 2023 vote on the same proposal was approved by the European Commission. European Health Commissioner Stella Kyriakides first proposed the postponement late last year to avoid tens of thousands of medical devices going off the market because they could not meet MDR requirements.

The European Parliament will eliminate the typical 20-day waiting period before publishing the amendment in the Official Journal of the European Union due to the urgent nature of the amendment. The amendment will take effect immediately upon publication in the Official Journal, which is now expected in late March 2023.