Essentials of European Medical Device Regulatory Affairs

Current - EU Medical Device Directives

• Medical device directive MDD Directive 93/42/EEC • Active implantable medical devices AIMD Directive 90/385/EEC • 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 2004/108/EC • Personal protection equipment

Directive

Directive

89/636/EEC

The Organisationfor Professionals inRegulatory Affairs

Regulations published June 2017

3 year transition period

Medical Devices Directive (MDD)

Medical Devices Regulation (MDR)

Active Implantable Medical Devices

Directive (AIMDD)

5 year transition period

In Vitro Diagnostics Regulation (IVDR)

In Vitro Diagnostics Directive (IVDD)

The Organisationfor Professionals inRegulatory Affairs