The EU Health Commissioner will propose extending the deadline for companies to comply with a new law governing medical devices, as doctors warn that 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.
Our patients expect medical devices of the highest quality and safe. Kyriakides said in written comments to Reuters that they had made important progress to put in place new requirements for patient safety.
We will announce an extension of the transition period in order to mitigate short-term risks, in order to mitigate any short-term risks. Kyriakides will make a proposal at a meeting of EU health ministers on Friday. She said in parliament last month she was considering amendments.
An amendment to the law is required to be made, according to a Commission source. Any changes to the law would have to be approved by the Council and Parliament.
Kyriakides didn't say anything about how long the extension would be.
The Medical Devices Regulation MDR came into effect last year and was introduced after the 2010 scandal of exploding breast implants manufactured by a French company that exploited loopholes to sell faulty products at profit.
It has more stringent requirements and higher safety standards than the directive it replaced.
All medical devices sold in the EU must be re-certified by May 2024, according to the new law.
A dozen doctors and manufacturers interviewed by Reuters say supplies of some products are running low even before the 2024 deadline.
The old system has expired certificates that are not renewed for five years, and companies are struggling to get new ones under the new law. They say the certification process is slow, cumbersome and costly.
The situation is becoming more worrying from the perspective of doctors. There are shortages of essential medical devices, and in many cases alternative devices are missing, according to Christiaan Keijzer, president of the Standing Committee on European Doctors CPME.
He said medical associations across Europe have reported problems with the supply of surgical instruments, particularly in paediatrics, orthopaedics and cardiology, as well as other devices such as binocular endoscopes, silicone adhesives and blood collection items.
The Commission released data this week ahead of Friday's meeting, which highlights the issue.
Around 8,000 devices have been submitted by manufacturers, but less than 2,000 have been approved.
The Commission said that only 7,000 certificates under the new system will be issued by the end of May 2024.
There are about 23,000 certificates under the old system that will expire by May 2024 without an extension, according to the Commission. It said about 4,300 of those will expire next year.
It's hard to determine the total number of products that could be affected by the fact that certificates cover multiple devices.