Relevant links:
The In Vitro Diagnostics Regulation
https://eur-lex.europa.eu/eli/reg/2017/746/oj
Guidance documents:
https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_ongoing_guidancedocs_en.pdf
https://www.medical-device-regulation.eu/mdcg-endorsed-documents/
https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021_mdsw_en.pdf
Proposed Artificial Intelligence Regulation
https://ec.europa.eu/newsroom/dae/redirection/document/75788
In House Exemption guidance for Northern Ireland (following Brexit)
Miscellaneous
Nando – Database with list of Notified Bodies
Cathrine Høgseth Nordhus
Preparing for IVDR
Department of Medical Genetics, Oslo University Hospital
Norway