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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