Learn about the key requirements, concepts, and the overall process for CE marking under the Medical Devices Regulation (MDR). The CE mark gives access to a market with 500+ million people.

The course will give you an understanding of the key requirements, which will provide:

  • Essential knowledge to understand Regulatory Affairs of medical devices in EU, e.g. in the position of top management, or a manager or project member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales
  • The ability to understand the demands of the subcontractor, supplier, OEM, authorized representative, importer, distributor, allowing better relationships between them and the legal manufacturer
  • A basis to learn later about implementation of CE marking projects

Online training courses: Connected Learning Live
You can attend this training course classroom based and online. Do you prefer the convenience of an online training course? View here for the available dates or read more about Connected Learning Live.

Combination discount

Attending several medical device courses is associated with special discount

Medical Device Directive (MDD) to Medical Device Regulation (MDR) transition course

Requirements of the Medical Device Regulation (MDR) course

Implementation of the Medical Device Regulation (MDR) course

1. Transition or Requirements MDD-MDR
2. Implementing CE Marking MDR
Combination training 1 + 2 


In-house training course
For more information about combination of courses or in-house training courses, please contact Training via +31 20 346 07 80 or send an email to training.nl@bsigroup.com