Doctors fear a lack of aids if the Medical Devices Ordinance is not extended.
(Photo: obs)
Brussels Under massive pressure from business, doctors, patient organizations and the EU Parliament, the EU Commission is initiating an amendment to the Medical Devices Regulation. In its current form, the law could soon lead to shortages of vital products, such as stents to keep blood vessels open, balloon catheters or surgical instruments.
Around 500,000 such medical devices are used in the EU, and their approval has so far been covered by 21,376 certificates. Higher requirements will be placed on these certificates in the future. The safety should be examined in studies, depending on the product, extensive documentation must be created.
But all this leads to lengthy bureaucratic procedures. And there are too few places that work through these procedures. In the old system, 80 notified bodies were busy issuing certificates. There are now stricter requirements for them too. 62 bodies want to participate in the new system, but only 36 of them have been notified so far.
The applications back up. According to industry sources, none have been processed in less than a year. Applications from manufacturers are increasingly being rejected due to a lack of capacity. In some cases, this involves products that have been in use for years without any abnormalities. By October 2022, two and a half years after the law came into force, 1990 new certificates had been issued – i.e. around a tenth of the old certificates had been renewed.
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Now EU Health Commissioner Stella Kyriakides wants to set significantly longer transition periods. High-risk products such as implants are to receive a new certificate by December 2027, other products such as syringes and surgical instruments by December 2028. Both would mean an extension of three years.
The first test extension was not sufficient
This would be enough time to go through the test processes. A first extension of the deadline in January 2022 was not sufficient. The new proposal means a new legislative process, which means significantly more work in the EU institutions. Products that have already been delivered should therefore continue to be used, even if the certificates expire.
This does not solve all problems. Companies had complained that the effort involved in bringing a medical device to market had increased significantly. The costs are difficult to bear, especially for small companies that produce products with small margins and small quantities. Several companies have withdrawn from the European market, citing the Medical Devices Ordinance as the reason.
>> Read here: Rising costs and bureaucracy – medical device manufacturers expect less profit
Nevertheless, the industry was mostly relieved: “It’s good that the Commission is now speeding up,” said the managing director of the Federal Association of Medical Technology, Marc-Pierre Möll. A fast legislative procedure in the Council and Parliament of the EU is now needed to ensure planning security.
The Commission stresses that its proposal does not compromise on safety. But patient representatives fear exactly that. The European Patients’ Forum had campaigned for a one-year extension of the deadline. “We hope that the three-year postponement, together with the other deadline changes announced by the Commission, does not indicate a lower level of ambition and willingness to implement the Medical Devices Regulation,” said Managing Director Anca Toma.
More: Medical device manufacturers warn of bottlenecks due to EU regulation.