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     

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