The new European Union Medical Device Regulation (2017/745/EU) applies requirements for medical devices that are sold in the EU. While Medixine’s existing platform for remote patient monitoring was CE-marked as a medical device under the previous legislation, future product launches will follow the orders of the new regulation and national legislation (719/2021).
The goal of the new legislation is to unify the regulation in the EU area and to further improve patient safety. While it is still allowed to sell devices that meet the earlier demands any updates or new product launches needs to be done according to the new regulation.
Medixine passed the first phase of MDR-certification in August, with additional phases to be completed this autum. The audit is being executed by Tüv Süd, a well known and highly regarded certification organization. Depending on the processing times, our product will receive the updated CE mark by the end of 2021 and be compliant with the latest regulation.
We most decidedly wanted to start the auditing process as soon as possible, even though we would have been allowed to sell our current products until 2024. It is important to us that our customers can always trust that our services meet the legislative standards. Being able to bring new functionalities to the market regularly is also an essential part of our high quality customer service. It goes without saying that under the new legislation any new solution for remote patient monitoring need a CE mark”, says Otto Teinonen, CTO of Medixine.
Demand for remote patient monitoring solutions is increasing
Home measurements and remote patient monitoring have rapidly gained popularity in both primary care and specialised medical care. Well-implemented self-care reduces the need for hospital care and improves the patient’s prognosis and quality of life.
For Medixine, the popularity is reflected in a clear increase of demand in Finland as well as international markets.
We have successful use cases for example in the treatment of various heart failures and pulmonary obstruction. Remote monitoring can also be used as a way to maintain quality of life rather than treatment of a specific disease, as NHS service providers Howz has shown. They use our platform together with remote patient monitoring to improve the well-being of dementia patients and their families”, tells Lasse Rousi, CEO of Medixine.
Medixine’s remote healthcare software provides comprehensive capabilities for remote monitoring. With Medixine Suite, it is possible to monitor and treat any disease or condition. Measurements such as blood pressure, body temperature, weight or steps can be taken by the patient at home. These are then transferred from the measuring devices directly to the professional’s dashboard via a Bluetooth connection. The platform assists nursing staff in both triage and assessing the need for follow-up care.