We currently see the biggest change of European legislation for medical devices ever taking place. The former MDD (Medical Device Directive) is replaced by the MDR (Medical Device Regulation). The new regulatory framework clarifies the regulation of software products with the aim of ensuring that medical technology services and products used in healthcare are safe and efficient. All medical devices and services launched after 26 May 2021 must be certified by a so-called Notified Body in order to be CE-marked in accordance with the MDR to be able to be sold on the European market.
So what does the new regulation mean in practice?
The MDR increases patient safety and creates clarity around what is expected of the manufacturer and the product. It also clarifies who is responsible for what during use. The MDR entails a considerable tightening of the requirements for technical documentation, benefit-risk evaluation, clinical evaluation, and after-market monitoring.
Platform24 is one of the first Swedish health tech companies to receive a MDR certification. Our product Triage24 is a digital automated solution for care guidance and triage and the first triage solution on the European market to be certified. The CE marking means that the product meets the new higher requirements for medical equipment and may be marketed in the EU. The certification also means that we can expand and develop the technical platform, which includes changes to the solutions and new functions.
The shift from MDD to MDR means significantly stricter requirements on the product including traceability, clinical evaluation and post-market surveillance but also on cyber security, usability and expertise among the responsible individuals.
Tobias Perdahl, Chief Medical Officer at Platform24, what has this meant for us as a company?
-The MDR certification has been a long and demanding process. But living up to these very strict standards is fully in line with Platform24’s mission to be a real key player in the transformation of care that is now underway. The higher expectations for usability and clinical evidence are important for us as a company as well as for care, in order for us to reach the goal of accessible, efficient and equal care across the board.
What changes might the new regulations mean for our customers?
Do you see any other interesting effects of the MDR certification?
-Yes, I think one interesting perspective is the high level of “user-friendliness” that is required to minimize risks related to deviant patient behaviours. Having our solutions MDR certified means they are required to be sufficient for every doctor and patient in the healthcare system. By bringing everything together into one single entry point, seamless flows are created for all users – staff, doctors and patients – not just the “digitally savvy” ones with a preference for digital care. All modules are accessible through the platform’s digital “Front Door”, which streamlines the user experience and allows the focus to be on patient care rather than technology, Tobias Perdahl concludes.
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