The new EU regulations MDR -Medical Device Regulation – which came into force in 2021, means a comprehensive change in the regulations for medical devices. The requirement for MDR certification ensures that the medical technology services and products used within healthcare are safe and appropriate.
Platform24 is one of the first Swedish healthtech companies to get certified according to class IIa. The company’s automated digital care guide Triage24, which has completed over 6 million triage transactions, is considered to be the first triage solution on the European market to be certified. The labeling means that the product is compatible with the latest regulatory requirements for medical devices.
– Achieving the MDR certification is a very important milestone for us and a proof that our digital solution for triage and care guidance is safe and lives up to the highest standards for medical equipment. This is absolutely crucial for us, for our customers and above all – for the safety of the patient, says Daniel Lillienau, CEO of Platform24.
The MDR certification means that Platform24’s product is now adapted and meets the new, stricter regulatory requirements for marketing a medical device in the EU. With this, the company can further expand and develop the technical platform, which includes making significant changes to the solutions and adding new functions.
– Our digitized triage flows must always have at least the same accuracy and quality as that achieved through traditional triage performed by healthcare professionals. We have invested a lot of time and resources in achieving the MDR certification and to our knowledge, Triage24 is also the first triage solution in the EU to be certified and receives CE marking, says Tobias Perdahl, Medical Director Platform24.
About Triage24
Triage24 is a digital, automated solution for care guidance and triage which, in accordance with the medical protocol chosen by the customer, guides the patient to the right level of care, time and place based on care needs, degree of urgency and possible listing information. Platform24’s existing triage solution is used by approximately half of Sweden’s regions, meaning it is integrated with the region’s healthcare and medical record system.
About European Medical Device Regulation (MDR)
The new EU regulation MDR, or Medical Device Regulation, came into force in May 2021 and replaced the previous European directives for medical devices. It represents the largest change in European standards for compliance with medical devices in over 20 years.
The main purpose is to create a clearer regulation of software products to ensure that the medical technology services and products used in healthcare are safe and appropriate. MDR entails a significant tightening of the requirements for technical documentation, benefit-risk evaluation, clinical evaluation, and monitoring of the aftermarket. All medical technology products and services launched after 26 May 2021 must be certified by a so-called notified body (“Notified Body”) in order to be CE marked in accordance with MDR and released on the European market.
