Healthcare professionals need to be aware that the Regulations are more stringent than the Directives: in general they retain the existing requirements and add new ones. The Regulations emphasise a life-cycle approach to safety, backed up by clinical data.
During the transition from Directives to Regulations and for a few years afterwards (until 2025), some products certified under the Directives and products certified under the new Regulations will coexist on the market.
The Regulations introduce new rules for in-house devices, custom-made devices, clinical investigations, reprocessing of single-use devices, and distance sales. They also require implant cards for patients. They strengthen the rules for the designation of notified bodies – the independent evaluators of manufacturers and their devices.
In addition, the Regulations introduce a system of unique device identifiers (UDIs) and a new European database for medical devices and in vitro diagnostic medical devices (EUDAMED). This will improve openness by making data available and increasing both the quantity and quality of data, and by enhancing the identification and traceability of medical devices.
