Europe set to postpone device regulation by one year

Europe set to postpone device regulation by one year

3 April 2020 - Deborah Wilkes

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

The Commission said the move would “allow member states, health institutions and economic operators to prioritise the fight against the coronavirus pandemic”.

The date of application has been put back from 26 May 2020 to 26 May 2021.

Commenting on the move, Margaritis Schinas – a vice-president of the European Commission with the portfolio for Promoting our European Way of Life – said “shortages or delays in getting key medical devices certified and on the market are not an option right now”.

“The Commission is therefore taking a pragmatic approach and delaying the entry into application of new European Union rules on medical devices, so we can have our medical industries pouring all their energy into what we need them to be doing: helping fight the pandemic,” remarked Schinas.

Schinas stressed that the European Union was “leaving no stone unturned” in its support to national public health systems in their hour of need.

The Commission said the new Medical Devices Regulation was needed to ensure patient safety and increase transparency on medical devices across the European Union, but the currently applicable rules would continue to guarantee the protection of public health.

Addressing potential shortages

The Commission added that the proposal ensured member states and the Commission could address potential shortages of vitally-important medical devices in the European Union in a more effective manner through European Union wide derogations.

The proposal needs the full support of the European Parliament and Council through an accelerated co-decision procedure.

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