Medical Devices CE Marking - MDR and IVDR

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 focuses on the safety and performance of medical devices, targeted on the requirements for placing them on the market.

The In Vitro Diagnostic Regulation (IVDR) describes the requirements that manufacturers must meet in order to sell IVDR devices within the European Union. IVDR training courses will introduce you to the requirements and implementation of IVDR.

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

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Medical Devices CE Marking - MDR & IVDR training courses

Implementation of Medical Device Regulation (MDR) for CE marking >

This course will help you to implement the requirements of European Medical Device Regulation (MDR) to obtain and maintain CE marks for your product, giving you access to a market with 500+ million people. Find out best practice for assembling Technical Documentation and QMS when placing Medical Devices (MD) on the European Union market.

€2150 excl. BTW

3 days

Training Technical Documentation for the MDR >

This one-day intensive course enables greater understanding of the key requirements for technical documentation for medical devices, in line with the European Medical Device Regulation (MDR) requirements in Europe. The aim of the course is to enable manufacturers to: create robust technical documentation to demonstrate compliance to the MDR and better understand regulatory requirements and Notified Body expectation, to prevent unnecessary delays to the certification process.

€875 excl. BTW

1 day