Big Changes by MDR

Big Changes by MDR

28.09.2018 – The MDR (Medical Devices Regulation) has been adopted on the 5th April 2017 and will replace the MDD (Medical Devices Regulation) and AIMDD (Active Implantable Medical Devices Directive). There is a transition period of 3 years making the regulation fully applicable in May 2020. There are massive changes compared to the MDD confronting manufacturers with numerous challenges. Further details can be found here.

The IVDR (In Vitro Devices Regulation) has been adopted on the 5th April 2017 and will replace the IVDD (In Vitro Devices Directive).  There is a transition period of 5 years making the regulation fully applicable in May 2022. There are massive changes compared to the IVDD confronting  manufacturers with numerous challenges. Further details can be found here.