Today the Council adopted a regulation which extends the deadline for the certification of medical devices. This measure aims to prevent that medical devices which cannot be certified by the initial cut-off date become unavailable for European patients.
Today we have agreed on measures that will allow the industry to continue bringing essential medical devices to the market and ensure that patients have safe access to medical devices.
Acko Ankarberg Johansson, Swedish minister for health care
A staggered and conditional extension
Producers of medical devices will now have until 31 December 2027 for higher risk devices and until 31 December 2028 for medium and lower risk devices to meet the legal requirements.
The extension of the transition period will be granted under certain conditions. These ensure that only devices that are safe and for which manufacturers have already started the certification procedure will benefit from the additional time.
Removal of “sell-off” date
The regulation adopted today also reduces the risk of medical devices shortages by removing the “sell-off” date rule. The “sell-off” date is the end date after which devices already on the market but not yet with the final user should be withdrawn. Only devices that comply with the previous EU law on medical devices will benefit from this rule. Removing the “sell-off” date will allow safe medical devices to remain longer on the market.
Background and next steps
In April 2017, the Council and the European Parliament adopted two regulations to improve the safety of medical devices and in vitro diagnostic medical devices. Medical devices cover a broad array of products, ranging from hearing devices and wheelchairs to catheters and orthopaedic implants. One of the measures of the 2017 regulation is a more robust conformity assessment system of medical devices. The amending regulation adopted today does not change the requirements of the original regulations of 2017.
Under this system, by the end of the foreseen transition period of 26 May 2024, all medical devices have to conform with the new rules. But because, among other things, conformity assessment bodies suffer from capacity problems to (re)certify old and new medical devices there is a risk that at the end of the transition period a large share of devices will no longer be available to EU patients.
The decision to extend the implementation period will enter into force on the day of its publication in the Official Journal of the EU.
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