The European Parliament on Thursday voted overwhelmingly to extend the Medical Devices Regulation (MDR) transition periods to avoid a shortage of life-saving products in the economic region. The vote also supported nixing the sell-off date provision for existing products specified in the MDR and In Vitro Diagnostic Medical Devices Regulation (IVDR).
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 vote was taken by Katarina Barley, vice president of the European Parliament, and 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 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. (RELATED: European Commission moves to delay MDR transition, Regulatory Focus 6 January 2023)…
