Requirements of the In Vitro Diagnostic Regulation Training Course

Learn about the key requirements of the new In Vitro Diagnostic Regulation (IVDR EU 2017/746), published in Spring 2017 with a five year transition period. To CE mark an IVD in Europe it will soon be mandatory to conform to this Regulation. The Regulation will affect all In Vitro Diagnostic device manufacturers, importers, distributors and EU Representatives.

Who should attend?

Manufacturers of In Vitro Diagnostic devices, in particular those who have not yet placed an IVD on the market in the EU, especially: Regulatory Affairs, Design and Development, Clinical Affairs Specialists, Quality Management, Quality Assurance personnel, and other Economic Operators including manufacturers, importers, distributors and authorised representatives who are new to, or have little familiarity with, the EU IVD market.

We also offer an equivalent training course for the requirements of the Medical Device Regulation for CE Marking.

What will I learn?

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

  • Identify devices that are within scope of the Regulation
  • Understand the roles and responsibilities of the different Economic Operators identified by the Regulation
  • Identify other key players and their obligations under the Regulation
  • Identify key requirements concerning the following steps for conformity assessment:
    • Determine the risk class of IVD
    • Select conformity assessment procedure
    • Identify applicable General Safety and Performance Requirements (GSPRs)
    • Recognise key elements of Technical Documentation
    • Appreciate the importance of product claims, labelling, Unique Device Identification (UDI) and EUDAMED (The European Database on Medical Devices)
    • Identify requirements of clinical evidence
    • Post-Market Surveillance and updates     

How will I benefit?

This course will allow you to:

  • Identify the key requirements of the In Vitro Diagnostic Regulation
  • Interpret and communicate the key requirements and expectations of the IVDR to your organization
  • Identify the next steps in planning of product realization and commercialization in conformity with the IVDR. 

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.