The European Commission on Friday (6 January) adopted a proposal to give suppliers an extra four years to re-certify medical devices, to circumvent the risk of shortages.

There are over 500,000 types of medical devices on the EU market, from hip replacements to sticking plasters, all covered by the Medical Devices Regulation (MDR). The MDR entered into force in 2017, and into application in May 2021, replacing the two-decade-old former directive.

In accordance with the regulation, all medical devices produced in Europe had to be re-certified by 26 May 2024. However, as many are struggling to reach the deadline – posing a risk of shortages, should uncertified devices are removed from the market – the Commission proposed a longer transition period to adapt to new rules, with revised deadlines based on the medical devices’ risk class.

“We will not allow any risk of significant disruption in the supply of various medical devices on the market, which would affect healthcare systems and their ability to provide care to European patients,” said Commission Vice-President Margaritis Schinas.

“Our proposal for an extension of the transitional periods for the application of the Medical Devices Regulation will address the risk of shortages of medical devices on the EU market.”

The length of the proposed extension of the transition periods depends on the type of device: higher-risk devices such as pacemakers and hip implants will have a shorter transition period, up to December 2027. Medium and lower-risk devices, such as syringes or reusable surgical instruments, will have an extension of up to December 2028.

For class III implantable custom-made devices the proposal introduces a transition period until 26 May 2026.

The Commission also proposed to remove the ‘sell-off’ date currently established in the MDR, to ensure that safe and essential medical devices that are already on the market remain available to healthcare systems and to patients in need.

The ‘sell-off’ date is the end date after which devices that have already been placed on the market and remain available for purchase, should be withdrawn, as explained in Commission’s press release.

Additionally, the proposal extends the validity of certificates issued up until 26 May 2021, to reflect the transition periods put forward by the amendments.

The reasons for the delay 

“We propose a revised regulatory timeline to provide certainty to industry in order to continue producing essential medical devices, reducing any short-term risk of shortages and safeguarding access for patients most in need,” said Health Commissioner Stella Kyriakides.

She added that it was “a combination of factors [that] left healthcare systems across the EU facing a risk of shortages of life-saving medical devices for patients”.

The main reason for shortages, according to the EU official, is the capacity of notified bodies and the preparedness of the manufacturers, together with the COVID-19 pandemic and war in Ukraine.

Now the baton is passed to the Parliament and the Council.

“I call on the European Parliament and the Council to quickly adopt the proposal. Member States and notified bodies should also work with industry to ensure the transition to the new rules provided for by the Medical Devices Regulation, without further delay,” Kyriakides concluded.

The delay was expected

Concerns about the implementation of the revision of the MDR were raised by both politicians and stakeholders last year. In April, the European Parliament highlighted manufacturers’ claims that it is impossible to have almost 20,000 technologies certified in such a short time.

At a plenary session in November, Kyriakides admitted that “as we move towards the end of the transition period, it has become extremely clear that ensuring patient access to these devices is not guaranteed”.

In December, the Commission presented “clear orientations” on the way forward at the EU’s Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), while the legal proposal came a month later.

Source: Euractiv.com