New EU regulations will soon be enforced to ensure greater patient safety by imposing more requirements on medical device manufacturers. The industry welcomes them, but fears it may hit small manufacturers particularly hard
– mostly because of a delayed implementation.
May 26, 2020.
For health tech companies this date can be a landmark. This is when the new Medical Device Directive (MDD) of the EU will come into effect.
“Greater consumer safety will be the main focus of these new guidelines. We had some pretty harsh European scandals back in 2012, and the rules in this area had already been outdated, which is why they needed to be revised,” says Lene Laursen, Deputy Director of Medicoindustrien, a medtech company hailing from Denmark.
The new MDR (Medical Device Regulation) drastically tightens the rules for medical devices. There will be new directives for clinical documentation, stricter regulations for notified bodies, and a pan-European database will be created where all products must be registered.
“There were two major weaknesses in the old system: there was a lack of clinical documentation for the products, and it was believed that some of the notified bodies did not keep close enough tabs on the manufacturers. These are the primary issues that are being addressed now, after five years of deliberation,” she explains.
However, similarly to how the regulation has taken a long time to be completed, the implementation phase is also being affected by delays. While the industry agrees with the increased focus on patient safety, the new rules might make life difficult for many small health tech companies.
MDR cut-off features
Daman is a scale-up digital health provider and the company behind HealthBuddy, a “patient empowerment platform” that helps those afflicted with chronic illnesses have a better life with the help of various digital tools. Although MDR has not yet come into effect, it is already forcing the small business to make changes to its product development strategy.
“Our field is between medical health and wellness. We are not exclusively a medical company, so there are some grey areas. At first glance, it isn’t clear if our product classifies as medical equipment. If we provide graphs based on the user’s own diary, MDR doesn’t affect us. But if we add algorithms that translate the reported data into a recommended action – e.g. reminding patients to take their medication – we enter the world of medicine,” says Andreas Dam, CEO of Daman.
With the help of data collection, even small improvements in the software can have a huge impact on patients. However, since the company is balancing on the edge of MDR territory, some of these new features have to be postponed.
“It’s important to take the safety of patients into account, but regulation sometimes clashes with innovation. What is unfortunate about the new MDR guideline is that we aren’t prepared enough to make the necessary changes in such a short time. Notified bodies are a huge challenge because they slow down the approval process significantly. We will have to halt our updates until we find out if we are approved, and small scale-ups like ours are not given priority. Therefore, the road to the market is also going to be longer,” Dam points out.
Notified bodies are a bottle neck
Currently, 58 agencies have permission to certify equipment in Europe. So far, only 12 of them have had their authorisation renewed under the new rules.
This low number increases the time it takes to get certified in a process that can take between 12 and 18 months. If you are a small business, finding a notified body that takes in new customers at all can be difficult.
“As a result, we have a lot of members who don’t even have a notified body, so they can’t get their product on the market. Naturally, this is bad news for the companies, but also has a negative effect on the healthcare system, too, which is missing out on new products,” Laursen says.
What makes this area special is that it is not run by the government, but by private companies that have approval to take on the task of certification. Under the new and tougher rules, fewer organisations want to take on this legally risky task. This means that Denmark loses its notified body, which instead becomes a branch of a Norwegian player.
“Danish companies can choose notified bodies elsewhere, but we still believe it is important that Denmark – as a country with a prominent life science industry – has its own notified body. This makes us very concerned on behalf of our health care service providers,” Laursen explains.
Right now, notified bodies are undoubtedly suffering, because of a bottleneck caused by MDR and its application. Though this explains the situation, it does not change the fact that Daman can’t get its products approved.
“Maybe it will be fine in a couple of years. But a few years is a really long time in this space, and the wait is very unfortunate for the patients,” Dam says.
An important part of MDR is a new pan-European database – EUDAMED – wherein everything from insulin pens, scalpels and scanners must be registered.
“According to the new rules, the database must contain all products on the European market, so that patients can see documentation that proves that the products have been clinically tested,” Laursen explains.
The problem is that the database is not expected to be completed until May 2022.
“The database is something everyone has been looking forward to, but it was officially delayed in the fall, 6 months before it should have been ready. And that’s a real shame, because many of the provisions in the MDR requires uploading documents to this database,” Laursen reveals.
She sees the postponement as a consequence of regulators wanting to tighten up the area to increase security and transparency after some unfortunate episodes without realising how much effort it would take to implement such changes. This leaves manufacturers with the question, “How will I comply the MDR without the database?”
Small businesses are under pressure
At Technolution –a consultancy firm that specialises in helping others develop medical devices – they also believe that MDR will hit small manufacturers and entrepreneurs the hardest because they do not have the resources and in-house skills to keep up with the new regulations.
Among other things, the four quality management experts in the company point to the stricter requirements for clinical data as a major challenge. With MDR, it is no longer possible to simply refer to comparable products: firms must have underlying data from the competitors’ clinical trials in order to get their product approved.
“This will be costly for small manufacturers and entrepreneurs. It is recommended to consult with a professional clinical advisor who can create the optimal process for getting the product approved by the authorities,” says Marianne Lind, manager of the Technolutions quality management team.
“Previously, PMS has not been clearly defined. It is now specified that for each product, a PMS plan must be prepared and reviewed, and the output of this analysis must be compiled into a summary report,” Lind explains.
Europe must be competitive
Daman might choose to look to the US or Israel for certification, as a consequence of the strict rules with no guidelines.
“There are still many things in the regulation that even experts do not know how to interpret into practice. After all, we get hit by MDR in 2 months. It would be a shame if we couldn’t create a competitive platform on the global market from Europe,” Dam points out.
At Medicoindustrien, the new rules are welcomed, but the company looks forward to May 26th with both hope and apprehension.
“The whole process has taken much longer than we had anticipated. We start to see that the obstacles are slowly beginning to disappear, but we also believe that we’re still really, really far from the end goal,” Laursen concludes.