The Commission is not closing the door to a major overhaul of the rules on medical devices.

In her speech to MEPs last week, Ursula von der Leyen outlined her healthcare policy agenda for the next five-year term – but the industry hopes she has further reforms in store.

In political guidelines presented on Thursday, the Commission president outlined plans for new rules on cybersecurity for hospitals, critical medicines and biotechnology before seeking approval from lawmakers for a second five-year term.

But von der Leyen remained silent on another issue the sector sees as crucial: addressing long-standing issues with EU rules on medical devices such as syringes, pacemakers and breast implants.

Healthcare stakeholders, led by health technology lobby MedTech Europe, had been hoping for some mention of reform of the legal framework and consider the lack of action in this regard to be a serious failure on von der Leyen’s part.

“Now is the time for urgent and effective reform and to ensure that the rules deliver benefits to patients,” MedTech Europe said in a note after last week’s vote.

The lobby group fears that the approval processes set out in current law could prove impossible in practice, leading to shortages of key products. New safety standards set out in 2017 EU regulations potentially require the re-approval and recertification of thousands of existing devices.

There were concerns that in practice many people would not complete all the formalities, meaning that key medical products would suddenly become unavailable on the EU market. To avoid the worrying prospect of shortages, Brussels repeatedly extended the transition period for authorisation, and the framework was never fully implemented.

Despite the lack of a clear reference from von der Leyen, the industry can still have hope.

A Commission spokesperson told Euronews that the EU’s executive body had started the necessary preparatory steps “to assess and review existing rules in order to address their shortcomings where necessary”.

“This assessment will allow for possible follow-up actions in line with the political direction of the next Commission,” he said, indicating that reform had not been ruled out.

What is it about?

The first overhaul of the EU regulatory framework for medical devices, which took place in 2012, aimed to improve outdated rules dating from the 1990s and to improve safety and availability.

In 2017, Brussels introduced additional rules on in vitro diagnostic medical devices, such as glucose meters for diabetes and HIV tests.

However, the diverse and complex structure of the EU industry makes it difficult to implement these rules in practice.

According to MedTech Europe, more than 15,900 patent applications for medical devices were filed with the European Patent Office in 2023 – an average of one new application every 30 minutes, in a sector in which 37,000 European companies, mainly small and medium-sized, operate.

This process is further slowed down by the fact that Member States have not designated bodies authorised to assess the conformity of products before medical devices are placed on the market.

“We call on the re-elect Commission President to make a swift and comprehensive reform (of medical devices) central to her health and competitiveness agenda, taking into account the conclusions of their targeted evaluation,” MedTech Europe said in a note.