EU MDR/IVDR
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published a guidance document describing the rules on healthcare institution exemption for medical devices. It is important to mention...
EU MDR/IVDR
The Notified Body Operations Group (NBOG), an organization established by the European Commission to improve the performance of notified bodies earlier in 2000, has published a best practice guide dedicated to the designation and notification of conformity assessment...
EU MDR/IVDR
The Notified Body Operations Group (NBOG), an organization established by the European Commission to improve the performance of notified bodies earlier in 2000, has published a best practice guide dedicated to the designation and notification of conformity assessment...
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 Medicinal and Healthcare products Authority (MHRA) has published an updated version of the guidance describing the new medical device regulations related to Brexit. In particular, the amended document provides additional details regarding the way medical devices...
