The European Commission has released the first guidance documents for the upcoming In Vitro Diagnostic Regulations (IVDR) and Medical Device Regulations (MDR).
On 5 April 2017, two new Regulations on medical devices were adopted by the European Commission, and they entered into force on 25 May 2017. These replaced the existing Directives, however, the new rules will only apply after a transitional period. Namely, three years after entry into force for the Regulation on medical devices (spring 2020) and five years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
The documents are endorsed by the Medical Device Coordination Group (MDCG) and provide guidance on basic UDI-DI and changes to UDI-DI (MDCG 2018-1), and future EU medical device nomenclature – Description of requirements (MDCG 2018-2)