A year late, the new EU-wide Medical Device Regulation (MDR) replaced the old directive in May 2021. Due to the stricter requirements, the MDR is a noticeable hurdle, especially for small and medium-sized enterprises. However, it also means one thing above all: more safety for consumers.
In the past decade, no medical device scandal has been as memorable as the case of the PIP breast implants. The manufacturer secretly used unsuitable industrial silicone in production, which was only discovered by the control authorities when more serious complications occurred.
This caused severe damage: some of the inferior implants had ruptured, and the leaking silicone gel caused painful inflammation of the surrounding tissue. To this day, there is an urgent suspicion that the material is carcinogenic. As a result, hundreds of thousands of women who had the product inserted were advised to have the implants removed – causing enormous financial, physical and psychological strain.
High quality standards, high requirements
It was scandals like this that drove the revision of EU-wide regulations for medical devices. On 26 May 2021, after a year of COVID-related postponement, a new EU-wide regulation of medical devices came into force: the Medical Device Regulation, or MDR for short.
The basic requirements for medical devices were significantly expanded in this regulation. These include a new classification of products, stricter requirements for approval, detailed guidelines for clinical testing as well as technical documentation and traceability of all production steps, but also ongoing safety evaluations after the launch of the product as part of post-market surveillance. In addition, each medical device is assigned a unique product identification number (UDI). This UDI enables better traceability of medical devices along the entire supply chain up to the end-user, which means that effective measures can be taken quickly in the event of any safety problems. The established CE marking of medical devices, on the other hand, remains unchanged.
Software for diagnosis, prevention, monitoring, prognosis and therapy of diseases also falls under the new regulation. Depending on the risk class, software products are affected to a greater or lesser extent by these tighter regulations. Quality management must now meet certain criteria, such as passing clinical examinations. A standard that was not required before.
A big challenge for the small ones
These stricter requirements are definitely a challenge. Small and medium-sized enterprises, in particular, have to change their operations at great financial and personnel expense.
Some SMEs now fear for their ability to compete and innovate, as large producers often already operate according to these standards and can more easily cope with an additional effort. Smaller companies could thus be degraded to mere suppliers of the large corporations in the tougher regulated competition. Some experts also fear that the changes in the classification of medical devices could lead to product bottlenecks, especially in the early days.
All of this is certainly a big challenge to overcome – but in the end, medical devices are always about one thing: being able to guarantee quality, performance and safety for users.
Using the new regulation for the better
The MDR can also be taken as an opportunity to rethink and improve processes in companies. This also means fine-tuning the quality of one’s product and entering collaborations in which resources can be shared meaningfully with competitors or partners.
In addition to increasing patient safety, the new laws also offer a comprehensive EU-wide database (EUDAMED), as well as greater legal certainty for manufacturers and partly simplified administrative processes. Until now, there have been a large number of independent, national databases. According to the current plans of the European Commission, this should be a thing of the past by 2022 with the introduction of EUDAMED.
What the MDR means for XUND
When we founded in 2018, the so-called Regulation (EU) 2017/745 on medical devices, or MDR for short, had already been a done deal for several months. Therefore, we were already confronted at that time with the initial situation that XUND, in the form we envisioned and ultimately implemented it, would have to be classified as a medical device. It quickly became clear to us that as a manufacturer of medical devices, we would be able to stand out much better from the mass of lifestyle and health apps and thus play a central role in the digitalisation of the healthcare system.
Hence, it was a logical step for us to make the company fit for the MDR right from the start. A key milestone in achieving this goal was the establishment of a quality management system following ISO 13485:2016. Certification in accordance with this standard is crucial for all medical device manufacturers and is required by the MDR so that the safety and functionality of the respective medical devices placed on the market can be proven.
In everyday business, this means for us as a tech company that the development cycles are much longer than in less regulated industries due to the required standardised processes. In addition, the regular inspections, so-called audits, by notified bodies such as a TÜV Süd are a cost factor that should not be underestimated, but at the same time helps us as a young start-up to increase trust in the quality of our products.
Overall, we expect the stricter regulation to clean up the market of solutions that were in the grey area under the previous regulation (MDD) and were thus able to evade corresponding supervisory and control mechanisms. Operating in such grey areas is no longer possible with the Medical Device Regulation (MDR), which has been in force since 26 May 2021, thus creating more credibility, safety and trust for all stakeholders in the healthcare sector.
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© 2021 XUND Solutions GmbH
© 2021 XUND Solutions GmbH