EU legal provisions




27/11/2023 – 01/12/2023


  • EU current directives and introduction to the new regulation;
  • Basic information on current Medical Device Regulations relevant for Blood, Tissue & Cells establishments (BTC) and defining the borderlines for novel BTC with other regulatory frameworks, in particular where medicinal products and medical devices are concerned;
  • Overlaps between Substances of Human Origin (SoHO), Advanced Therapy Medicinal Products (ATMPs) and Medical Devices frameworks.

Learning objectives

  • To facilitate a harmonised interpretation of the EU legislative framework;
  • To deepen awareness of the connection and interaction of SoHO legal provisions with medical devices, ATMP and medicinal products legislation and their impact on inspections and authorisation of novel processes.

Required and Additional reading

Click to view and download the document (pdf)

Download eLearning week 1 module programme (pdf)