Europe
The National Center for Expertise of Medicines and Medical Devices (NDDA), a Kazakhstan`s body responsible for the premarket assessment of medical devices, has published an official announcement about the implementation of the new importation and exportation rules for...
EU MDR/IVDR
The European Commission (EC), a union-wide authority responsible for medical devices regulations, has announced the launch of the first of six EUDAMED modules – the Actor registration module. Intended Purpose According to the official announcement published by...
EU MDR/IVDR
The Medicines and Healthcare products Regulating Agency (MHRA), the UK agency responsible for medical devices regulations, has published guidance describing the way the study sponsors should notify the authority about a clinical investigation for a medical device. The...
EU MDR/IVDR
The Medicines and Healthcare products Regulatory Agency (MHRA) has published detailed guidance dedicated to the new regulations that will take effect from January 1, 2021. Starting from the aforementioned date, the authority would be fully responsible for all...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG) has published a Q&A dedicated to conformity assessment procedures for protective equipment. The document has been developed to provide the manufacturers and other parties involved with additional information to achieve...
EU MDR/IVDR
The European Commission (EC), a legislative body of the European Union, has adopted a regulation dedicated to the common specifications for the reprocessing of single-use devices. Regulatory Background The new Commission Implementing Regulation (EU) 2020/1207 is...
