European Parliament decides to postpone new Regulation (MDR 2017/745) for medical devices

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European Parliament decides to postpone new Regulation (MDR 2017/745) for medical devices

On 17th April 2020, Parliament adopted the Commission proposal, by urgent procedure with 693 votes, allowing the application of the Medical Devices Regulation to be postponed by one year until 26 May 2021.

The European Parliament is supporting this proposal to allow authorities and manufacturers alike to prioritise the fight against the coronavirus pandemic by continuing under current procedures, because 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 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.

https://www.europarl.europa.eu/news/en/press-room/20200415IPR77113/parliament-decides-to-postpone-new-requirements-for-medical-devices