Meeting the In Vitro Medical Devices Regulation In-house Training

The In vitro Medical Devices Directive has been the route to CE marking of in vitro medical devices in Europe since 2002. In 2017 the new In Vitro Medical Devices Regulation (IVDR) was published and comes into force in May 2022. From this moment all IVDs must comply with the new IVDR. At the moment around 20% of IVDs require notified body intervention prior to be being placed on the market, under the new regulation this will increase to around 85%. The new regulation has many more requirements than the current directive and whilst most are not going to prove ‘difficult ‘ to implement, there is much to do in the time left available. The aim of this event is to provide all those involved with IVDs a broad overview of the IVDR with practical guidance to navigating the additions and expectations of the law.

EVENT INTRODUCTION

The In vitro Medical Devices Directive has been the route to CE marking of in vitro medical devices in Europe since 2002. In 2017 the new In Vitro Medical Devices Regulation (IVDR) was published and comes into force in May 2022. From this moment all IVDs must comply with the new IVDR. At the moment around 20% of IVDs require notified body intervention prior to be being placed on the market, under the new regulation this will increase to around 85%. The new regulation has many more requirements than the current directive and whilst most are not going to prove ‘difficult ‘ to implement, there is much to do in the time left available. The aim of this event is to provide all those involved with IVDs a broad overview of the IVDR with practical guidance to navigating the additions and expectations of the law.

• IVD Regulatory Affairs managers • IVD Quality Managers • IVD Quality Engineers • Manufacturers of IVDs for the EU • Designers of IVDs for the EU • Anyone tasked with IVDR implementation

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