Software under Medical Device Directive (MDD) vs. Medical Device Regulation (MDR)
References
Medical Device Directive (MDD): https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:EN:PDF
Medical Device Regulation (MDR): https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0745&from=EN#d1e32-140-1