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

LONDON, Dec 8 (Reuters) – The EU health commissioner will propose on Friday to extend 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 shortage of rescue equipment.

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

“Our patients expect medical devices to be safe and of the highest quality. We have made important progress in implementing new requirements for patient safety, but challenges remain,” Kyriakides said in emailed comments to Reuters.

“That is why, to mitigate any near-term risks, we will announce an extension of the transition period tomorrow to mitigate any shortage risk.”

Kyriakides will make the proposal at a meeting of EU health ministers on Friday. She said in parliament last month that she was considering amendments.

A commission source said the extension will require an amendment to the law. Any legal changes would have to be approved by the Council and Parliament.

Kyriakides did not comment on how long the extension would be.

The Medical Device Regulation (MDR) came into force last year and was introduced after the 2010 scandal of the explosion of breast implants made by a French company that exploited loopholes to sell faulty products at a profit.

It has more stringent requirements and higher security standards than the policy it replaced.

Under the new law, all medical devices, from implants and prostheses to blood glucose meters and pacemakers sold in the EU, must be recertified by May 2024.

A dozen doctors and manufacturers interviewed by Reuters say supplies of some products are running out even before the 2024 deadline.

This is because certificates that were valid for five years under the old system are about to expire and companies are scrambling to get new ones under the new law. They say the new certification process is slow, cumbersome and expensive.

“From the perspective of physicians, the situation is increasingly worrying. We are already seeing shortages of some essential medical devices and, in many cases, a lack of alternative devices,” said Christiaan Keijzer, President of the Standing Committee of European Physicians (CPME). . ), he told Reuters.

He said medical associations across Europe have reported problems with the supply of surgical instruments, especially in paediatrics, orthopedics and cardiology, as well as other devices such as binocular endoscopes, silicone adhesives and blood collection items.

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

Manufacturers have submitted applications for about 8,000 devices, but fewer than 2,000 have been approved.

At that rate, only 7,000 certificates will be issued under the new system before the May 2024 deadline, the commission said.

The Commission said there are about 23,000 certificates under the old system that will expire in May 2024 without an extension. About 4,300 of them will expire next year, he said.

The certificates cover multiple devices, making it difficult to estimate the total number of products potentially affected.

Information from Maggie Fick; edited by Josephine Mason and Elaine Hardcastle

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