Medical Devices CE Marking - MDR & IVDR courses

Medical Devices CE Marking - MDR & IVDR courses

Discover all Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) training courses.

Discover all Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) training courses.
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MDR
The Medical Devices Regulation (MDR) is the legislation setting out the requirements that manufacturers must meet in order to market medical devices in the European Union. It affects all manufacturers, importers, distributors and representatives of medical devices within the EU. The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), has a transition period of three years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.

IVDR
The In Vitro Diagnostic Regulation (IVDR) describes the requirements that manufacturers must meet in order to sell IVDR devices within the European Union. The IVDR (EU) 2017/746 is the new EU legislation applicable to in vitro diagnostic (IVD) medical devices. Entering into force on the 25 May 2017 marking the start of a five-year transition period for manufacturers and economic operators, the IVDR replaces the EU In Vitro Diagnostics Directive (IVDD) 98/79/EC. 

Would you like to comply with both legislation and customer requirements? Then BSI's MDR and IVDR training courses are suitable for you.

Medical Device Regulation (MDR) & In Vitro Diagnostic Regulation (IVDR) courses

Why train with BSI?

We understand the challenges of meeting regulatory requirements and maintaining quality management systems. We understand because it’s what we do, every day of every week; for you, for your customers, and for your bottom line.

We have dynamic course owners around the world, allowing delivery of training in many local languages. Our course owners are subject matter experts and use practical examples from their experiences to bring each lesson to life.