Regulatory
manufacturers, in part due to challenges they faced hiring, training and maintaining expert reviewers. Conformity assessment is still a significant bottleneck. In 2022, at least 15% and up to 30% of SMEs still had no access to an MDR-designated notified body, according to MedTech Europe, the European trade association representing the medical technology industry. That figure was 53% for IVD manufacturers. And, fast forward another two years, and there are still key elements of the new legislative framework that have not fully been implemented, including the highly- anticipated EUDAMED system – a centralised database designed to provide a living picture of the life cycle of medical devices that are made available in the EU.
Time to reflect Petra Zoellner, Director of Regulatory Affairs (IVDR & MDR) at MedTech Europe, says the combination of implementation delays and gaps in the system itself have led to a host of challenges for manufacturers when it comes to both keeping devices on the market and bringing new devices to patients across Europe. “Not only has progress been slow in implementing the regulations, we’ve also seen deficiencies at the system level,” she says. “The way it has been set up has resulted, both pre and post-market, in a system that is unpredictable, slow, complex and unclear. The ground seems to be changing every year with regards to what is expected from manufacturers and there is little clarity on timelines for conformity assessments or transparency from notified bodies on their fees. It’s challenging for large manufacturers to understand what they need to do, but those challenges are magnified even further for SMEs, which make up most of the market.
“In many cases, companies have used the new regulations as a chance to reflect and this has been leading to the discontinuation of devices that have been on the market for many years, as well as companies deciding to carry out their first launch outside of Europe, because of the cost implications and unpredictability of the system here in Europe.” Indeed, research from MedTech Europe in 2022 showed that MDR is currently a disincentive against launching medical device innovation in the EU, with 54% of medical device manufacturers not intending to transition some of their portfolio to the MDR and approximately 50% deprioritising the EU market as the geography of choice for first regulatory approval of their new devices. Another survey also showed that at least 22% of IVD tests on the market today will be discontinued due to the implications of the IVD Regulation. More recent research carried out in Germany in 2023 by the German Chamber of Commerce and Industry (DIHK), the MedicalMountains cluster initiative and the German
Medical Device Developments /
www.nsmedicaldevices.com
industry association SPECTARIS, tells an even more alarming story: across all 21 application areas and product groups surveyed, 53% of all product ranges have at least partially discontinued sales of products in the EU because of the burden of the MDR. This has significant knock-on impacts for patients, with research from the Biomedical Alliance in Europe showing that many clinicians are increasingly concerned about the rising number of essential devices that are no longer available for use in medical care for various reasons, and reporting that this is affecting the quality of care that they can provide to their patients.
A welcome proposal – if it’s done right After three deadline extensions in both the MD and IVD sector over the last seven years, in early 2024, manufacturers are once again in a position where the regulatory goalposts could be moved. The latest proposal from the European Commission includes measures to extend the transition period for IVDs, enable a gradual roll-out of the new electronic database EUDAMED and require manufacturers to flag up potential shortages. According to Zoellner, while MedTech Europe supports the intent behind the European Commission’s proposal – to help prevent medical device shortages and encourage greater transparency – that support comes with certain caveats. “We will support anything that improves device availability for patients,” she notes. “But it is crucial that regulators use this extra time to ensure that the wider system becomes drastically more efficient and that it becomes easier for everyone to transition to the two new regulations.” An important part of the new proposal is that EUDAMED modules will be made mandatory as soon as they are available and functional. Under the previous provisions, the use of EUDAMED would only become mandatory when all six modules – actor registration; unique device identification; notified bodies and certificates; clinical investigations and performance studies; post-market surveillance and vigilance; and market surveillance – were ready. The new proposal would allow the mandatory use of several modules to start from the end of 2025. For Zoellner, this is a welcome update. “We have been waiting for the system for years,” she says. But, again, there are caveats to MedTech Europe’s support of the deadline change. “We need to be sure all the parts will work together once the whole database is rolled out and we need a very clear date communicated well in advance as to when manufacturers will be expected to use and populate the system,” Zoellner emphasises. “The
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