3. History of Medical Device regulatory framework in the EU

History of Medical Device regulatory framework in the EU

Three directives formed the initial EU regulatory framework for medical devices: the Active Implantable Devices Directive of 1990 (90/385/ EEC or ‘AIMDD’), the Medical Devices Directive of 1993 (93/43/EEC or ‘MDD’), and the In Vitro, Diagnostic Directive of 1998 (98/79/EC or ‘IVDD’), and several subsequent legal acts amended these directives. For instance, the 2007 amendment to the Medical Devices Directive introduced stricter and more explicit requirements in the area of clinical evidence and introduced software as medical device [5].

The EU has revised the regulatory framework on Medical Devices and on 26 May 2021, the AIMDD and MDD were repealed and replaced by the new Medical Device Regulation (Regulation 2017/745 or ‘MDR’), which served to modernise and strengthen the requirements on device safety and performance throughout their lifecycle while increasing harmonisation of how those requirements are applied across the Member States. On 26 May 2022, the new In Vitro Diagnostic Medical Devices Regulation (Regulation 2017/746 or ’IVDR’) follows after a five-year transition period, repealing and replacing the IVDD. At the time of writing though, there are discussions among EU institutions to potentially adjust this timeline in order to give the IVDR regulatory system more time to be built. The European Commission has published several additions to the MDR and the IVDR and it is expected that more changes/finetuning by the Commission will follow.