Regulatory
of experts like EirMed, which streamline the process using templates and software.
Despite the EU’s introduction of IVDR legislation in 2017, device manufacturers are still facing problems transitioning to the new regulations.
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
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“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 time- consuming, 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.” ●
Medical Device Developments /
www.nsmedicaldevices.com
MMD Creative/
Shutterstock.com
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