The new Medical Device and In Vitro Diagnostic Medical Device Regulations (MDR and IVDR, respectively) are coming, is anyone ready?
The new European Medical Device and IVD Regulations adopted in May 2017 replace the existing Medical Devices Directive (MDD), In Vitro Diagnostic Directive and Active Implantable Medical Devices Directive (AIMDD). The new regulatory framework will apply after a transitional period, which ends May 26th, 2020 (May 26th, 2022 for IVDs), and from that date on the new Regulations will fully apply.
Did you already start the transition to Medical Device Single Audit Program (MDSAP)? The clock is ticking!
As of January 1st, 2019, Health Canada will terminate the Canadian Medical Devices Conformity Assessment System (CMDCAS) program and Canadian Medical Devices Conformity Assessment System certificates will no longer be issued or accepted.