The European Union’s Council of Ministers has today adopted a resolution to extend the deadline for the certification of medical devices under the Medical Devices Regulation (MDR).
Producers of medical devices will have until Dec. 31, 2027, for higher risk devices and until Dec. 31, 2028, for medium and lower risk devices to meet the legal requirements.
The extension of the transition period will be granted under certain conditions, ensuring that only devices that are safe and for which manufacturers have already started the certification procedure will benefit from the additional time.
The regulation—which changes the way that medical devices are certified for use in the European market—first came into effect in 2021 with an initial three-year transition period, having been delayed by one year in 2020 due to the onset of the COVID-19 pandemic. However, challenges in the implementation of the legislation led to concerns about a potential shortfall in the availability of certain devices, which prompted a rethink in the timetable for the regulation as proposed by the European Commission in December.
Today’s adoption of the resolution by EU Council members, comprising ministers from each of the EU’s member states, means that the decision to extend the implementation period will enter into force on the day of its publication in the Official Journal of the EU.
“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, Sweden’s minister for healthcare, was quoted saying.
MedTech Europe, which represents the continent’s device manufacturers, has welcomed the adoption of the amended transitional provisions, which it said will help mitigate the immediate risk that medical devices across all areas of medicine, which are still on the EU market, would no longer be available after May 2024.
“The amendment of the Medical Devices Regulations’ transitional provisions is a needed step forward to help ensure that more medical devices remain available to patients and healthcare systems across Europe. This decision grants Notified Bodies more time to complete certification of more than 500.000 medical devices and accelerates efforts to certify innovative devices in the pipeline,” says Oliver Bisazza, CEO of MedTech Europe.
As soon as the amendment comes into force, MedTech Europe said that alongside its members it will work toward its implementation according to the new provisions and extended deadlines.
“In that regard, it is important that all stakeholders have an aligned and clear interpretation of the amendment, including the process for submitting applications to Notified Bodies, and how the extended validity of certificates can be concretely demonstrated,” the organization’s statement adds.