EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a guidance document dedicated to the current classification rules. The document is intended to assist medical device manufacturers...
EU MDR/IVDR
The European Medicines Agency (EMA) has published guidelines dedicated to the quality documentation to be provided for medicinal products intended for use with medical devices. The present article addresses matters related to medicinal products with co-packaged or...
EU MDR/IVDR
The European Medicines Agency (EMA) has published a guidance document dedicated to the quality documentation for medicinal products when used with a medical device. The present document constitutes a final version which will enter into force on January 1, 2022. Table...
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...
Europe
HDR UK will release seven new health data hubs, providing over 100 doctors, scientists, and researchers with the medical histories of millions of NHS patients. They aim to aid research for new medicines, treatments, and technologies across the country, HDR’s...
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