Essentials of European Medical Device Regulatory Affairs - October 2019

Current _ EU Medical Device Directives

• Medical device directive   MDD

Directive 93/42/EEC Directive 90/385/EEC

• Active implantable medical devices AIMD • e.g pacemakers • In vitro diagnostic medical devices  IVDMD

Directive 98/79/EEC

• E.g pregnancy testing kits • Directives that also impact devices • Electromagnetic compatibility

Directive 2004/108/EC Directive 89/636/EEC

• Personal protection equipment

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Regulation 2017/745 MDR Regulation 2017/746 IVDR

3 year transition period Ends May 2020

Medical Devices  Directive  (MDD)

Medical Devices  Regulation  (MDR)

Active Implantable  Medical Devices 

Directive  (AIMDD)

In Vitro Diagnostics  Regulation  (IVDR) 5 year transition period Ends May 2022

In Vitro Diagnostics  Directive  (IVDD)

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