The European Commission has released the first guidance for the upcoming Medical Device Regulations (EU MDR) and In Vitro Diagnostic Regulations (IVDR).
Both the EU MDR and IVDR replace the existing Directives, however, the new rules will only apply after a transitional period. For MDR, this period is three years after entry into force (spring 2020). For the IVDR, this period is five years after entry into force (spring 2022).
More recently in March of 2018, a document regarding the requirements for a future EU medical device nomenclature was endorsed at the meeting of the European Medical Devices Coordination Group (MDCG). Access the full document here.Continue Reading