Europe proposes to delay implementation of MDR due to COVID-19

The European Commission is working on a proposal to delay the implementation of the EU 2017/745 Medical Devices Regulation (MDR …

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EMA launch of International Sterile Medicines Inspection Pilot Program

European Medicines Agency (EMA) launched a 2-year pilot that would allow regulators all across the world to share information on …

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European Commission released 8 documents for unique device identifiers (UDIs) for medical devices

The European Commission released 8 documents relating to technical specifications for unique device identifiers (UDIs) for medical devices. 4 of …

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European Commission released an aide memoire on practicing good distribution practice (GDP)

The European Commission released an aide memoire to assist pharmaceutical wholesalers in practicing good distribution practice (GDP). The 6 page …

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Eudamed upcoming plans

The European Commission database of Medical Device information (Eudamed) will only be operational once all modules are fully functional and …

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