3. Additional Resources on MDR and IVDR
MDR and IVDR
The MDR and IVDR have introduced new responsibilities for many organisations in the healthcare sector, including the European Medicines Agency (EMA) and national competent authorities in the assessment of certain classes of medical devices.
A full playlist of MedTech Europe training videos on MDR and IVDR can be accessed here:
For a more detailed overview of the various steps a manufacturer must typically go through in order to make its device compliant with the MDR, refer to this factsheet: Implementation Model for medical devices Regulation Step by Step Guide
(Resource from European Commission, https://ec.europa.eu/health/sites/default/files/md_newregulations/docs/md_manufacturers_factsheet_annex_en.pdf)
For information about the MDR rules specific to implants, this factsheet may also be of interest: Factsheet for Manufacturers of Implantable Medical Devices
(Resource from European Commission, https://ec.europa.eu/health/sites/default/files/md_topics-interest/docs/md_implany-cards_factsheet_en.pdf)