2 new Regulations (MDR and IVDR) are replacing the 3 existing Directives.They entered into force on 25 May 2017 and will progressively replace the existing directives after a transition period.

• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Starting May 2021.
• Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Starting May 2022.

Medical devices within the EU are currently regulated by 3 Directives:

• Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990)
• Council Directive 93/42/EEC on Medical Devices (MDD) (1993)
• Directive 98/79/EC of the European Parliament and of the Council on in vitro Diagnostic Medical Devices (IVDMD)

Visit  https://ec.europa.eu/health/md_sector/overview_en for more information