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 guidelines on quality documentation for medicinal products when used with a medical device. The provisions of the guidance are based on the following regulations: Directive 2001/83/EC (the Medicinal Products Directive)...
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 Medical Device Coordination Group (MDCG), an advisory body composed of representatives of all Member States who are focused on the improvement of the existing regulatory framework, recently issued guidance dedicated to medical devices containing ancillary...
Europe
The European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) issued detailed information on Brexit to assist medical device manufacturers in dealing with issues related to changes associated with the transition period. Due to...
