The proposal now must be adopted by the European Parliament and Council through an accelerated process, a statement from the Commission said.

EU Health Commissioner Stella Kyriakides tabled the proposal last month, citing challenges in implementing the law were threatening supplies of critical devices, such as catheters used for surgeries on newborns with heart conditions.

Reuters reported last month that many companies are withdrawing devices from the EU market, or have stopped making them due to the cost it takes to comply with the rules.

(Reporting by Maggie Fick in London; Editing by Josephine Mason)