European Directives and Regulations

Current Directives on medical devices

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)
• Council Directive 98/79/EC on in vitro Diagnostic Medical Devices (IVDMD) (1998)

New Regulations on medical devices

On 5 April 2017, 2 new regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746) were adopted. They entered into force on 25 May 2017 and will progressively replace the existing directives. The new regulations will be fully applicable in May 2020 for medical devices and May 2022 for in vitro diagnostic medical devices.

Corrigenda

• Corrigendum to Regulation (EU) 2017/745 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Directives 90/385/EEC and 93/42/EEC
• Corrigendum to Regulation (EU) 2017/746 on in vitro diagnostic medical devices, repealing Directive 98/79/EC and Commission decision 2010/227/EU