European medical devices companies may end up having more time to become compliant with the Medical Devices Regulation (MDR), which went into effect in 2021 and concerns the clinical validation and sale of medical devices for use on patients in European Union countries.
The law replaced the Medical Device Directive, which was introduced in 1993 to harmonize laws and create common standards around medical devices for all EU members to follow. It also replaced Directive 90/385/EEC, which was enacted in 1990 and laid out requirements for manufacturing, importing and marketing active implantable medical devices under the CE Mark.
The MDR originally required all devices to be recertified by May 2024, but the European Commission approved delaying the deadline to the end of 2027 and the end of 2028 for devices, depending on each one’s individual risk classification, reported Reuters
Now, the proposal must be adopted by the European Parliament and Council through an accelerated process.
The push for a delay was spurred by the cost that companies would have to undertake to comply with the MDR’s more stringent requirements and safety standards, with many companies withdrawing devices from the EU market or stopping manufacturing because of the cost, according to Reuters
EU Health Commissioner Stella Kyriakides, who tabled the proposal in December 2022, also said that challenges with implementing the law put at risk supplies of critical devices, such as catheters for surgeries on newborns with heart conditions.
EU Health Ministers showed support for the delay, according to Robert J. Kerwin, general counsel for IAMERS (the International Association of Medical Equipment Remarketers and Servicers) who serve as the association's approved industry observer to the EU Medical Device Coordination Group, in an op-ed he wrote for HCB News
Among other things, he says, the certification process includes the undertaking of on-site audits of a manufacturer’s quality management systems and if applicable, the manufacturer’s subcontractors.
Despite the delay sparing some devices from being discontinued or pulled off the market in the short-term, it does not solve the logjams and high costs that are making companies question going through the process, several executives told Reuters last month.
"From the perspective of doctors, the situation is becoming more and more worrying. We are already seeing shortages of some essential medical devices, and in many cases alternative devices are missing," said Christiaan Keijzer, president of the Standing Committee of European Doctors (CPME), at the time.
The regulation was introduced in 2010 in the aftermath of a scandal involving exploding breast implants designed by Poly Implant Prothese, a French company that exploited loopholes to sell its product, according to news outlet MassDevice
The company designed its implants with a cheaper, industrial-grade silicone that was not approved for medical use and led to the implants rupturing at double the industry average. This put patients at risk, as the silicon gel caused inflammation and possible scarring. Questions about other long-term risks were also raised.