Medical Devices - Antaris Consulting

Transition from Medical Device Directive to Medical Device Regulation

Introduction ‘The Medical Device and In Vitro Medical Device Regulations represent the most significant change to European legislation for medical devices in over 20 years’ (Hoxey). As of the fifth of May 2017, new MDR and IVDR regulations have been approved and published by the European Commission. The new regulations will replace the directives; MDD, […]

EU Medical Device In Vitro Diagnostic Medical Device Regulations November 2017

The EU’s Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) came into force on 25 May 2017 and will replace the EU’s current Medical Device Directive (93/42/EEC) and the Directive on active implantable medical devices (90/385/EEC). Manufacturers of currently-approved medical devices will have a transition time of three years until May 26th 2020 to meet the […]

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