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The Genotype Network
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Ea Wright
Home
About
LifeLines
Contact
The Genotype Network
LE4D Global Regulatory Service
Home
About
LifeLines
Contact
The Genotype Network
LE4D Global Regulatory Service
Medical Devices, European Commission Elisabethann Wright 17/06/2025 Medical Devices, European Commission Elisabethann Wright 17/06/2025

New Manufacturer’s Incident Report PMSV reporting forms - European Commission (Copy)

The European Commission has published a new reporting template for Manufacturer Incident Reports (MIR) for Serious Incidents (SI). The template will become obligatory in November 2025.

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Medical Devices, Manufacturer's Incident Report, European Commission Elisabethann Wright 17/06/2025 Medical Devices, Manufacturer's Incident Report, European Commission Elisabethann Wright 17/06/2025

New Manufacturer’s Incident Report PMSV reporting forms - European Commission

The European Commission has published a new reporting template for Manufacturer Incident Reports (MIR) for Serious Incidents (SI). The template will become obligatory in November 2025.

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Critical Medicines, European Commission Elisabethann Wright 05/05/2025 Critical Medicines, European Commission Elisabethann Wright 05/05/2025

Proposal for Critical Medicines Act

The European Commission has presented its proposal for a Critical Medicines Act. The main purpose of the proposed Act is to limit the EU dependence on third country sources of critical medicines and encourage domestic production.

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Artificial Intelligence, Guidelines, European Commission Elisabethann Wright 03/03/2025 Artificial Intelligence, Guidelines, European Commission Elisabethann Wright 03/03/2025

Commission publishes Guidelines on the definition of an artificial intelligence system established by the AI Act

The European Commission has published Guidelines on the definition of an artificial intelligence system established by Regulation (EU) 2024/1689 (AI Act) file:///C:/Users/ewright/Work%20Folders/Downloads/Guidelines_on_the_definition_of_an_artificial_intelligence_system_established_by_AI_Act_VJp35Ve5WA4XFrpUSFj5ohfaBco_112455.pdf

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