Requirements of the Medical Device Regulation for CE Marking Training Course

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

Who should attend?

  • New starters in Regulatory Affairs (RA), personnel increasing their responsibility in this area, and RA professionals who are not familiar with the European MDR
  • Personnel working with Regulatory Affairs departments, e.g. top management, manager or project member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales
  • Staff working for organizations that partner with Medical Device manufacturers, e.g. as subcontractor, supplier, OEM, authorized representative, importer, distributor, auditee etc.

We also offer an equivalent training course for the requirements of the In Vitro Diagnostic Regulation.

What will I learn?

By the end of the course delegates will be able to:

  • Communicate the key requirements and concepts within the Regulation
  • Reference the necessary aspects to evaluate if and how your company is affected by MDR and to what extent
  • Define the vocabulary used within MDR
  • Explain the structure and administration of the Regulation
  • Recognize partners of manufacturers affected by the Regulation
  • Describe key steps of a conformity assessment
  • Explain the main impacts on the QMS relating to MDR
  • Recognize requirements for post-market surveillance and updates

How will I benefit?

This course will help you:

  • Understand the key requirements and concepts of the European Medical Devices Regulation
  • Communicate the impact of the key requirements introduced by the MDR to your organization

What's included?

  • You will gain 8 CPD points on completing the course
  • Training course notes
  • Lunch
  • Refreshments

 

In-house training

If you have a group of people to train and a single location that is practical, an expert tutor can deliver training at your premises. Want to know more?

 

Request an in-house training quote >


COVID-19: Important information on classroom-based training courses

BSI is closely monitoring UK Government Advice regarding the safety of classroom-based training courses. We’ve been working with all our venues to ensure that COVID secure measures are in place and a member of our team has visited each venue to personally check things over. Enhanced cleaning procedures have been implemented, food and beverage offers adapted, and meeting room layouts have been modified to enable socially distanced events – with anti-bacterial gel and wipes readily available.

If you have any questions regarding your booking of a classroom-based training course, please contact training@bsigroup.com or call +44 345 086 9000.