Exclusive: EU to propose delay to medical device law amid supply worries

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The EU Health Commissioner will on Friday propose extending the deadline for companies to comply with a new law regulating medical devices, she told Reuters on Thursday as doctors warn the legislation is causing shortages of lifesaving equipment.

Stella Kyriakides told Reuters that challenges in implementing the law were threatening supplies of critical devices, such as catheters used for surgeries on newborns with heart conditions.

Kyriakides will make the proposal at a meeting of EU health ministers on Friday. She said in parliament last month she was considering amendments. That's because certificates which last for five years under the old system are expiring and companies are struggling to get new ones under the new law. They say the new certification process is slow, cumbersome and costly.

Data released by the Commission in a statement this week ahead of Friday's meeting highlights the issue.

 

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