Europe moves closer to postponing device regulation

Europe moves closer to postponing device regulation

20 April 2020 - Deborah Wilkes

The European Parliament has adopted the European Commission’s proposal to postpone by one year the date of application of the new Medical Devices Regulation.

Parliament adopted the proposal by 693 votes to one and two abstentions, allowing the date of application to be put back to 26 May 2021.

The proposal now has to be approved by the member states of the European Union and published in the Official Journal before it enters into force. This is expected at the latest by 26 May 2020.

Commenting on the proposal in early April, the European Commission said the move would “allow member states, health institutions and economic operators to prioritise the fight against the coronavirus pandemic” (click here to read the News story).

The European Parliament said the move would “prevent shortages or delays in getting key medical devices on the market”.

“Given the current pressure on national health authorities and manufacturers of medical devices,” said the European Parliament, "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 of this year.”

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