MDR: The regulations increase security when care is digitalised

What does the new regulation mean in practice?

The MDR increases patient safety and clarifies the expectations 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 health tech companies to receive an MDR certification for our products, which is Triage24 and Smart Care Plans.

Triage24 is a digital automated solution for care guidance and triage and the first triage solution on the European market to be certified. With Smart Care Plans, you can create dynamic and personalized monitoring and episodic care plans, with questionnaires, hardware measurements, appointments and more.

The CE marking means that the products meet the new, higher requirements for medical equipment and may be marketed in the EU. The certification also enables us to expand and develop the technical platform, which includes updates to the solutions and the addition of new functions.

The shift from MDD to MDR implies significantly stricter requirements for the product, including traceability, clinical evaluation, and post-market surveillance, as well as cybersecurity, usability, and expertise among the responsible individuals.

Stina Perdahl, Chief Medical Officer at Platform24, what has this meant for us as a company?

• “The initial MDR certification was a long and demanding process, and the process also continues after the initial certification. But living up to the rigorous standards is fully in line with Platform24’s mission to be a real key player in the transformation of care that is now underway. Raising expectations for usability and clinical evidence is important both for us as a company and for the healthcare sector. This means reaching the goal of accessible, efficient and equal care across the board.” says Stina Perdahl, CMO

How does MDR affect healthcare providers?

• “I would say that it creates an advantage for you as a customer and care provider, now having proof that the functionality claimed by the manufacturer actually is verified. It increases security for both healthcare providers and end users, which in turn brings credibility to the benefits and safety that digital medical technology software entails. It also becomes easier for the customer to make demands for updates from a life cycle perspective. With an MDR-certified product, the customer can feel certain that the provider has long-term qualifications to conduct responsible product development within medical technology software.” Stina Perdahl, CMO.

Do you see any other interesting effects of the MDR certification?

“Yes. I think one interesting perspective is the requirement to look at the clinical benefit for the patients. To continuously monitor and evaluate the actual clinical data from the use of the medical device to create real value for patients using it. Another interesting perspective is the requirement for usability engineering, meaning creating user-friendly products for all patients to use. This is a very important aspect for equal care for all.” Stina Perdahl concludes.