The European Parliament on Friday voted decisively in favor of a proposal to delay by one year the implementation of the EU's Medical Device Regulation.
The proposal was crafted by the European Commission and was moved forward last week by the Council of the EU in hopes of allowing the medical device industry to prioritize its coronavirus response efforts.
Friday's approval — with 693 votes in favor, 1 against, and 2 abstentions — clears a key barrier to the enactment of the delay, but the proposal now has to be approved by the member states and published in the Official Journal before taking effect. According to Parliament, those actions are expected at the latest by May 26, MDR's original enforcement date.
After months of escalating alarm about the May 26 date of application, the European Commission proposed delaying MDR by a year late last month. The disclosure of the proposed delay two months before MDR was due to come into force gave the EU a narrow window in which to put the plan into action.
Earlier this month, the Commission and Council did their parts by supporting a proposal to postpone implementation of MDR. The actions of the Commission and the Council advanced the plan to a vote in Parliament.
The Parliament's decision was based on wanting to prevent device shortages and delays in getting products on the market against constraints posed by the pandemic.
The body said in a press release following the vote that a delay would "allow authorities and manufacturers alike to prioritise the fight against the coronavirus pandemic by continuing under current procedures."
The In Vitro Diagnostic Regulation, slated to take effect in 2022, remains unaffected.
The number of notified bodies available to take MDR work, as listed in the European Commission's database, still stands at 12. The EC has not confirmed any new notified bodies for MDR for almost a month.