These documents include:
These documents include high-level information concerning the main changes introduced by the MDR and IVDR, guidance concerning the transitional provisions or the Regulations and “frequently asked questions”. The step-by-step implementation model documents could be useful for manufacturers to plan transition to the new Regulations or to determine which steps they still need to take.
Please contact our team if you have any question in relation to the implementation of the Regulations or these new guidance documents.
Authored by Fabien Roy and Helene Boland