periodic safety update report(English)

• must be provided at least annually by manufacturer for all Class IIb and III devices, based on surveillance and PMCF
• CVMP, IBD, AE, CEAR, CECP, CENELEC, CER, EFPIA, EGA, DG SANTE, EUDAMED, IVD, IVDD, IVDR, MDCG, MDR, NANDO, PMCF, SSCP, UDI, DLP, ICH
• Safety and health, Pharmacology / pharmaceutics, Health care industry
• https://doi.org…rheartj/ehaa382
• https://www.law…data-lock-point