19 Apr: The New Medical Device Regulation (MDR)

Medical Device (MD) manufacturers are confronted with major changes in the EU’s decades-old relevant regulatory framework. The Medical Device Regulation (MDR) entered into force on May 25th 2017 will progressively replace the EU’s current Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC) until May 26th 2021 and May 2022 respectively.