Europe’s health commissioner, Stella Kyriakides, has announced that proposals to extend the transition period for the implementation of the European Union’s (EU) Medical Device Regulation (MDR) will be put forward in early 2023.
Kyriakides informed health ministers from the EU’s 27 member states of the plan at a meeting of the Employment, Social Policy, Health and Consumer Affairs Council in Brussels on Friday (9 December), where the council members discussed the current status of the implementation of the MDR.
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.
Concerns have been raised over the impact of the transition to the new regulatory regime, with the European Society of Cardiology (ESC) last week calling upon ministers to act to prevent a “shortfall of essential medical devices for cardiovascular patients”, which the Society warned could include diagnostic and ablation catheters and some stents.
At Friday’s meeting, Kyriakides informed ministers that she will propose an extension to the transition period for the implementation of the MDR in early 2023—with the measure then to be voted upon by the European Council and Parliament.
“Patients rightly expect to have safe and high-quality medical devices,” Kyriakides told journalists at a press conference that followed the council meeting, where she acknowledged it is now a “crucial time” for the transition to the new rules.
“We have been following the progress achieved towards this goal very closely in the past months and, while the number of notified bodies have increased and actions have been taken to prepare manufacturers, this is not enough,” Kyriakides added. “In addition, we are now experiencing supply shortages on the global market. We are still feeling the impacts of the pandemic, and now also the Russian war in Ukraine, where several manufacturers of devices are located. This is creating additional complications.
“This is why I announced today to ministers that we will propose to extend the transition period to mitigate any short-term risks. This targeted amendment will take into account the risk class of different devices and address the sell-off date. At the same time, we will work on medium- and long-term solutions to address the more structural issues that have arisen with the new rules.
“Our citizens do not only expect medical devices to be safe, they also expect them to be available. We will do everything in our power to ensure that this transition does not create any disruptions.”
