In 2017, the EU introduced new rules for medical devices and in vitro diagnostics (IVDs) to modernise the sector, increase trust, improve patient safety and create a more harmonised European legal framework for medical device safety and performance. Up until this point, Europe’s medical device regulations had only been updated once since their inception in the 1990s, while the rules for IVDs had remained the same for more than 30 years. By 2017, both sectors were in severe need of more oversight and an up-to-date system to improve traceability and transparency.
However, despite the need for a regulatory overhaul, particularly for IVDs, progress has remained slow in transitioning to the new rules. For the first years of the transition period, this was largely down to the fact that the infrastructure manufacturers needed to comply with the new regulations was still being put into place. Part of the new framework is the designation of ‘notified bodies’, which control the process of conformity assessment for the majority of classes of medical devices. But the notified bodies that were designated in the early years of the transition were simply unable to handle the demand that was coming their way from 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 highlyanticipated 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 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 system has been delayed a couple of times already so it’s crucial that the industry knows when this is happening and has all the information they need to engage effectively with the database.”
The European Commission’s proposal also requires a notification from manufacturers about interruption of supply at least six months before the interruption happens for devices, which are critical for patients or public health.
“MedTech Europe supports the intent behind this measure,” Zoellner says. “However, it has a strong potential to add administrative burden to all actors, so it is important that it is implemented in a pragmatic and efficient way. For example, EU reporting should supersede any national reporting requirements.
“Given that there was no public consultation beforehand, it is also important that the measure is reviewed six months after it is implemented to check how it is working and make any needed modifications. Taken together, all of this would support transparency (due to Eudamed) and can help prevent shortages (due to the transitional period’s extension).”
Making the most of EUDAMED
At present, according to Richard Houlihan, CEO of EUDAMED consultancy EirMed, which helps manufacturers achieve compliance with EUDAMED requirements, there is little urgency amongst manufacturers to transition to the new system. “We have a good core of companies that are entering their data into the system, but there are also a huge number of manufacturers that are sitting back and waiting until the Commission finally decides the system is going to go live,” he says. The problem with that is that the process of populating EUDAMED has taken some companies up to two years, although a year is generally sufficient for manufacturers to understand what is required, get their data together and enter it into the system, especially with the help of experts like EirMed, which streamline the process using templates and software.
“The issue many manufacturers have is that they are doing this on the side; they’re not treating it as a proper project,” Houlihan says. “But it’s hugely timeconsuming, especially if they are trying to enter their data manually. And while they’re doing that, they’re not spending time on their day jobs. They need to understand that this is going to become a legal requirement. No matter how good, bad or confusing it is, they will have to use it. There’s no choice in this.”
Houlihan also believes many manufacturers are missing a huge marketing opportunity by not making the most of the database. “There’s a field in there for a URL for more information, and while people don’t have to enter it, I am encouraging them to fill it in. Distributors and importers are already using this as a product catalogue, which is something I never expected. When everything is up and running, this is going to be a fantastic resource not only for authorities to get more clear oversight, but also for the industry itself.”
According to Zoellner, the structural issues inherent in the European medical device regulatory system cannot be solved through the implementation of IVDR and MDR alone. “We don’t want to start from ground zero; we certainly want to keep the regulations we already have. But comprehensive reform is also needed in three key areas: efficiency, innovation and governance,” she says.
In a nutshell, MedTech Europe is calling for a regulatory system that provides clear timelines, clear costs and no surprises so that manufacturers can plan how to comply with the relevant requirements both pre- and post-market. The organisation would also like to see the development of clear innovation pathways and the establishment of a single accountable governance structure to oversee the whole system.
It’s a vision MedTech Europe will continue to fight for. But in the meantime, as the MDR and IVDR deadlines continue to draw closer, their advice for medical device manufacturers is twofold. One: be alert to the deadlines that apply to the types of devices you manufacture. Two: tell your authorities if you are having significant problems either meeting those deadlines or understanding the regulatory requirements.
“We are seeing a lot of smaller companies going out of business, which has led to the discontinuation of devices, but authorities had no idea that those businesses were encountering difficulties,” Zoellner explains. “Talk to them and they may be able to point you to funding or expertise. More often than not, they will take action to support manufacturers. But you must keep them informed.”
