From MDD to MDR

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 This directive has been replaced by the European Regulation 2017/745 (MDR), which has been officially effective since 26th of May, 2021.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Also the European Directive 98/79/EC for in-vitro diagnostic medical devices (IVDD) has been replaced by a regulation, the European Regulation 2017/746 (IVDR).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.