The European Society of Cardiology (ESC) has urged European Union (EU) health ministers to act to prevent a “shortfall of essential medical devices for cardiovascular patients”, caused by challenges in the implementation of Europe’s Medical Device Regulation (MDR). Diagnostic and ablation catheters and some stents are among the devices which may have limited availability, ESC said in a statement.
The ESC’s call came ahead of an Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) meeting today (9 December), where ministers discussed ongoing challenges in implementing the MDR and the resulting risk of safe medical devices being removed from the EU market.
The regulation came into effect in 2021 with an initial three-year transition period applied. Implementation was delayed by 12 months due to the COVID-19 pandemic. Concerns about the transition to the MDR led the ESC, along with the Biomedical Alliance in Europe, to survey physicians on devices they use that are no longer on the market.
ESC detailed that 49% of respondents had experienced issues with the availability of medical devices since the MDR was enacted. The reported causes for unavailability of devices included manufacturers withdrawing products due to the length and cost of MDR recertification and, in parallel, disruptions of supply chain and delivery issues.
In its statement, ESC added that it supports the MDR’s aim to enhance patient safety by improving the standards of clinical evidence required for medical devices, and welcomes the measures suggested by the Medical Device Coordination Group (MDCG) to facilitate the transition to the MDR. However, the ESC said that it believes stronger action is needed to avert the added threat to public health while healthcare systems are still recovering from the COVID-19 pandemic.
The ESC has invited the European Commission and Member States to consider extending the recertification deadline of 26 May 2024. During this additional period, notified bodies should be given extra capacity to process recertification applications, while manufacturers would have more time to adjust to the regulations and cope with supply chain problems. The ESC also asks regulators to explore the opportunity for joint procurement actions to counteract shortages.
As summarised by the chairman of the ESC Regulatory Affairs Committee, Piotr Szymański, “solutions are urgently needed to mitigate the medical devices crisis, that threatens medical procedures, research and innovation in Europe”.