EU Parliament decides to postpone new requirements for medical devices

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To prevent shortages or delays in getting key medical devices on the market, Parliament decided to postpone the application of the Medical Devices Regulation.

Parliament adopted the Commission proposal on Friday, by urgent procedure with 693 votes to 1 and 2 abstentions, allowing the application of the Medical Devices Regulation to be postponed by one year until 26 May 2021.

Given the current pressure on national health authorities and manufacturers of medical devices, there is a fear that there could be shortages or delays in getting the medical devices needed to fight COVID-19, were they to follow the new rules of the Medical Devices Regulation from May this year.

The European Parliament is therefore supporting the proposal to postpone the application of this Regulation by one year to allow authorities and manufacturers alike to prioritise the fight against the coronavirus pandemic by continuing under current procedures.

Next steps

The proposal now also has to be approved by the member states and published in the Official Journal before it will enter into force. This is expected at the latest by 26 May.



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