Following a warning from health ministers, the EU executive agreed on a list of actions to ease the transition into the new framework for medical devices as its sluggish implementation threatens a shortage in Europe.
The list was approved by the Medical Device Coordination Group (MDCG) chaired by the European Commission on Monday (29 August) and is meant to address the issues raised at the Employment, Social Policy, Health and Consumer Affairs EU Council in June.
At that time, the EU health minister warned that there were troubles for developers of medical devices in meeting the deadlines for implementing the two key regulations for medical devices (MDR) and in vitro diagnostics (IVDR), respectively, entered into application on May 2021 and May 2022.
Delays in complying with the regulations could result in issues with getting certification for medical devices, threatening shortages on the market.
“The measures we are announcing today are designed to address the immediate challenges to the availability of medical devices for patients in the EU,” said Health Commissioner Stella Kyriakides in a statement on Monday.
The difficulties in implementing these new frameworks are mostly linked to the fact that many devices need to be registered, alongside the limited capacity of medical device authorities.
The medical device certificates required under the new rules have not been issued yet for more than 85% of the over 500,000 devices registered under the previous regime, according to the EU’s medical device trade association Medtech Europe.
The association also estimates that 15 to 30% of small and medium-sized enterprises (SMEs) in the sector still have no access to a notified body under the new MDR rules.
Regarding in vitro diagnostic medical devices, only seven designated notified bodies are available for manufacturers, who keep facing issues registering both current and innovative devices.
In vitro diagnostic medical devices are tests used on biological samples to determine the status of a person’s health, ranging from self-tests for pregnancy to diagnoses performed in clinical laboratories.
Considering the lack of notified bodies to assess the conformity of these devices, the Commission has already proposed a progressive roll-out of the main provisions of the IVDR regulation to avoid significant disruption in the supply of various essential devices on the EU market.
“Working together, we are committed to finding sustainable solutions to ensure their availability at all times and avoid shortages as a matter of priority,” Kyriakides concluded in her statement.
The actions presented on Monday by the Commission include the advice that medical device authorities should “use hybrid audits, organise structured dialogues with manufacturers to improve the efficiency of the conformity assessment process, and provide support to small and medium-sized enterprises (SMEs) and new applicants.”
Contacted by EURACTIV, a MedTech Europe representative welcomed the ‘overwhelming majority of solutions proposed in the MDCG guidance’, as they could increase industry access to the notified bodies and help prevent device disruption.
However, the industry representative stressed the need for further discussion and clarification on some practical implementation details suggested by the Commission, such as the timing and the empowerment of stakeholders to implement them.
They also recall that “the options currently on the MDCG’s table are not sufficient, given the magnitude of the structural challenges holding the MDR and IVDR back,” suggesting that additional, even legislative, measures will be needed and should be further elaborated with the EU lawmakers.
[Edited by Alice Taylor]
