Pandemic and supply shortage among factors in slow transition to new rules.
With thousands of outstanding conformity assessments for medical device certification under the Medical Device Regulation and limited capacity to manage these within the transition period, concerns over widespread product shortages in the EU market have been growing.
To mitigate this risk, the European Commission proposed an extension of the transition period.
European Health Commissioner Stella Kyriakides noted that “the transition to the new rules has been slower than we anticipated,” and pointed to several contributing factors:
It was estimated that 23,000 devices and 1,500 In Vitro Diagnostics (IVDs) certified under the previous directives had not yet transitioned to the new regulation, and these certifications were likely to expire in May 2024 and May 2025, respectively.
As the end of 2022 approached it became clear that, with just 36 Notified Bodies designated for medical devices and only 8 for IVDs, there would not be sufficient capacity to maintain existing products on the market and also bring new products and innovations to EU markets.
This created the potential for shortages of life-saving medical devices for patients, which Kyriakides noted was “a risk that we cannot take.”
With these concerns in mind, Kyriakides proposed at a meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) in Brussels that the MDR transitional deadlines be postponed.
The proposal to the Council and the European Parliament included:
This targeted amendment was proposed to include staggered deadlines, depending on the risk of each device, and the extensions are to be subject to certain conditions to ensure they apply only to devices that do not present any unacceptable risk to health and safety. These devices should also not have undergone significant changes in design or intended purpose, and manufacturers are expected to have undertaken the necessary steps to launch the certification process under the MDR.
Kyriakides also proposed that the council consider prioritizing orphan devices, since these are crucial for treating relatively small groups of patients, especially children. Further support for orphan devices through the EU4Health Programme was mentioned with a focus on pediatrics.
These proposals have been welcomed by stakeholders and address many of the issues and unintended consequences from the MDR and IVDR introduction.
The EC’s stated aim has always been to support a regulatory environment for devices that will foster innovation, and now it is proposing practical steps to help in this regard.
This will be targeted to manufacturers of:
The EC has allowed these timeline extensions to help Notified Bodies to focus on the critical tasks at hand: ensuring patient safety and reducing bureaucracy.
There has also been further support detailed for SMEs with the aim of providing better access to Notified Bodies which would benefit industry, innovation and ultimately patients.
Nevertheless, the new developments raise some questions, and these will need further direction and guidance. These include:
The successful transition of combination products and companion diagnostics will need good integration and interaction with EMA, and, if the legal proposal is accepted, further guidance in this area is also required.
Companies should continue to transition to the MDR and IVDR as soon as they can, since this will allow them to focus on marketing and improving their products. Moreover, there may be future bottlenecks with Notified Bodies as the new deadlines approach, and companies that are ready to transition will be better able to market MDR/IVDR approved products globally.
On January 6, the EC adopted the proposal to delay the full implementation of the MDR. The EU parliament and council now need to issue final approval for the proposal, which will be processed through an “accelerated co-decision procedure.”
Sean O´Dowd, director, medical devices/IVD, PharmaLex