Previously, the European Directive 93/42/ EEC for Medical Devices (MDD) was applicable. This directive has been replaced by the European Regulation 2017/745 (MDR), which has been officially effective since 26th of May, 2021.
This new regulation merges the Medical Device Directive (93/42 /EEC) and the Active Implantable Medical Devices Directive (90/385/EEC).
Also the European Directive 98/79/EC for in-vitro diagnostic medical devices (IVDD) has been replaced by a regulation, the European Regulation 2017/746 (IVDR). This regulation is effective since 26th of May, 2022.
In these regulations on medical devices a number of things are different from the "old" directives. For example, there is more focus onclinical evidence for the medical device, and some products (especially software) fall into a higher class. Additional procedures for when the medical device has been placed on the market, have been formulated (post-market surveillance and post-market clinical follow-up). High-class devices will be more rigorously monitored, and more unexpected audits might occur.
A European database, Eudamed, will be created in which information about all medical devices will be collected.
Find out which laws and rules must be met to bring medical devices on the market in the EU.
Find out the meaning of some important terms in the MDR.