On 26 May 2021, the new EU regulation on medical devices (MDR) came into force. The regulation is to set out a uniform and safe framework for the manufacturing and distribution of medical devices in the EU.
New EU regulation is meant to enhance patient safety and the availability of new medical devices by underpinning the marketing and tightening the surveillance of the devices. The existing rules were adopted in the 1990s and are not up to date with the great scientific and technological development in this area.
For more information on the background for the new EU regulation, go to Danish Medicines Agency newsletter (in Danish).
Another significant aim of the regulation is to ensure traceability across the EU through the new European database, Eudamed. Several Member States have established their own registers, which are not always compatible.
The implementation of Eudamed will improve the transparency and coordination of information about medical devices on the EU market. The register is comprised by six modules, the first of which is in production, the second is in the test phase, and the remaining four modules are expected to be fully functional within the next few years.
The regulation will also ensure uniform processes for clinical testing, which means that all authorities in the EU must comply with the same requirements to, for instance, applications and deadlines.
A new element of the application process is that the Danish Medicines Agency and the new state scientific research medical committees will cooperate on applications.
Custom-made devices and use of AI and ML in medical devices
A task force comprised by experts and established by the EU Commission and the Medical Device Coordination Group (MDCG) has prepared a Q&A, answering the most urgent questions concerning the definition of custom-made medical devices and the requirements set out for the devices.
In addition, due to a large demand for specific guidance in the area, the Medicines Agency has prepared a FAQ concerning the use of artificial intelligence (AI) and machine learning (ML). To support the vast development in the area, the Agency is engaged in the EU Commission's issuance of common European guidelines for manufacturers who wish to apply AI in their medical devices.