The European Parliament has adopted a proposal to postpone new EU rules on medical devices by one year to prioritise getting key products on the market amid the coronavirus Covid-19 pandemic.
Parliament adopted the European Commission proposal to delay the application of the medical devices Regulation until 26 May 2021 "by urgent procedure", it said in a statement. The vote on 17 April saw 693 MEPs in favour and one against, with two abstentions.
"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 statement said.
Adopted in April 2017, the Regulation includes a 0.1% concentration limit for category 1A and 1B carcinogenic, mutagenic and reprotoxic (CMR) substances and endocrine disrupting chemicals (EDCs) in certain devices.
The decision to delay the Regulation now has to be approved by the EU Council of Ministers and will then be published in the Official Journal. It is expected to enter into force "at the latest" by 26 May.
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