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
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.
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.
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
- Detailed training course notes
- A loan copy of the standard, for use during the course
- Internationally recognized BSI Training Academy certificate