The health technology field in Europe has been buzzing for the past couple of years about medical device legislation. The new Medical Device Regulation (MDR 2017/745) has been applied in EU- and ETA countries since May 2021. It aims to unify the regulation in the EU area and further improve patient safety – but like transformations usually, it has not come without difficulties. We listed three things that healthcare providers and ICT decision-makers should know regarding the situation.
1. It’s time to act now
The regulation is already legally binding. A transition period is going on until May 2024, and from that onwards, all medical devices in use must be certified under the MDR. The medical device certification takes on average 13-18 months, so it is time to act now to make sure your service keeps running after May 2024.
Start with checking if your software qualifies as a medical device under MDR regulation. If you are acquiring a new system, remember to keep the MDR-compliant CE mark among the other criteria.
2. Pay attention to the devices you already use
Using a medical device that was placed on the market and met the requirements of the previous directive (MDD) is legal only until May 2024 – and only for certain devices that meet specific requirements. For example, an MDR-compliant clinical evaluation needs to be done for the medical device to retain permission to use it.
If changes to old devices are made, they must be brought into compliance with MDR (you cannot change them under the old rules). Every new device put into use must already comply with MDR.
Read more: Medixine Suite platform for remote patient monitoring now has the MDR-compliant CE IIa marking
3. HealthTech market is changing
Despite the new legislation already applying and final deadline approaching fast, only 15 % of medical devices are holding a new CE certificate under MDR.
HealthTech associations and healthcare authorities all over Europe have pointed out the situation as very alarming. One of the concerns is that currently, the resources of notified bodies in Europe are not enough to cover all the companies that need to start the auditing process. There is a risk that a significant amount of previously CE-marked medical devices would not get the new certification on time.
The new regulation also demands a lot from medical device companies. Regulation itself is four times wider than the previous directive and sets high device safety and quality standards. This hopefully leads to improved patient safety, which is certainly welcomed by everyone.
The downside might be that companies get overwhelmed with increased costs and liabilities that come with the heavy auditing process. This may lead them to decrease their product portfolios and target the innovation to markets outside Europe.
Want to learn more about medical device regulation? Contact our experts and let’s have a chat!