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. In the event of a classroom-based course being deemed unsafe, your training booking will be automatically transferred to online delivery using our highly-interactive virtual classroom - Connected Learning Live.

If you have any questions regarding your booking, please contact info.nl@bsigroup.com or call +46 (0)707 401147.


Booking a course delivered via Connected Learning Live?

Take advantage of our exclusive offers, only available in July and August 2020*

Book a July or August Connected Learning Live course date and you’re entitled to unlock one of the following benefits:

  • Option 1: Get 50% off a second delegate booking fee
    Offer applicable to public courses delivered via Connected Learning Live in July and August 2020 only. Second delegate must attend the same course date
  • Option 2: Save £500 on a BSI Diploma in Quality Management
    Offer applicable to delegates that have booked a public course delivered via Connected Learning Live in July and August 2020 only

Contact our training team today to find out more and book your place. Call +46 (0)707 401147 or email info.nl@bsigroup.com

*Terms and conditions: Applies to all public BSI UK training courses, taking place in July and August 2020 via Connected Learning Live only. Call our training team on +46 (0)707 401147 or email info.nl@bsigroup.com for more information. Second delegate must attend the same course date as the first delegate. Moves, changes and cancellations are not permitted. Payment required or invoice issued at the time of bookings. This offer does not apply to BSI re-sellers or Cybersecurity and BRCGS courses. Offer is for new BSI UK training bookings only. Offer is not to be used in conjunction with any other offer. Offer subject to availability of training courses. Bookings are non-transferable. All other terms and conditions for training courses apply.