The European Commission says it has approved delaying the deadline for companies to comply with a new law regulating medical devices in order to prevent shortages of lifesaving equipment.
A statement by the EU executive says the proposal now must be adopted by the European Parliament and Council through an accelerated process.
EU Health Commissioner, Stella Kyriakides submitted the proposal last month, saying challenges in implementing the law were threatening supplies of critical devices, such as catheters used for surgeries on new-borns with heart conditions.
Our 🇪🇺 rules on medical devices rules will always prioritise patient safety, security of supply and support for innovation.
Today, we propose to give time and certainty to industry, in order to reduce risks of shortages and ensure access for patients in need. https://t.co/HN0n80eapa
— Stella Kyriakides (@SKyriakidesEU) January 6, 2023
The law requires all devices to be re-certified by May 2024, but the new proposed deadlines push that back to the end of 2027 and the end of 2028, depending on the risk classification of the device.
The availability of safe medical devices for European patients is our priority.
We adopted a proposal to give more time to certify medical devices and adapt to the new rules.
This will mitigate the risk of shortages and safeguard access for patients most in need.#HealthUnion
— European Commission 🇪🇺 (@EU_Commission) January 6, 2023
The Medical Devices Regulation came into effect in 2021 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. Reuters reported last month that many companies were withdrawing devices from the EU market, or have stopped making them due to the cost it takes to comply with the rules.
While the delay would mean some devices will not be cut in the short term, it would not address the log jams and high costs discouraging firms from going through the process, several executives told Reuters last month after the Commissioner tabled the proposal.
