The European Medical Device Regulation (Regulation (EU) 2017/745, MDR) came into force on 25 May 2017 with a transition period which ended on the 25 May 2021. It replaces both the Medical Devices Directive 93/42/EEC (MDD) and the Directive relating to Active Implantable Medical Devices 90/385/EEC (AIMDD).
Several months ago, Guerbet launched its strategic project around MDR compliance. It has already ensured that the medical devices we manufacture, import and distribute comply with the requirements of this new regulation which are applicable as of 26 May 2021.
Some of the Guerbet product ranges have already transitioned to EU MDR CE marking. However, to ease the transition between the current Directive 93/42 (MDD) and the new Regulation 2017/745 a grace period described in MDR Article 120 (2) allows MDD certificates to remain valid until the end of the period indicated on the certificate.
Therefore, Guerbet is working closely with its EU Notified Bodies (which are already notified under MDR) to ensure that the remaining product ranges are transitioned to MDR CE marking prior to the end of validity of their current MDD certificates. As soon as the transition is completed, we will inform you and send you the respective MDR EC certificates.
Acting VP, Quality Technical Operations
EU MDR Strategic Project Manager
Reference - I21000817