Essentials of European Medical Device Regulatory Affairs

European Regulatory Agencies

European Commission (EC) Legislation produced for both medicines and devices Medical devices http://ec.europa.eu/growth/sectors/medical-devices/

Medicinal products http://ec.europa.eu/health/human-use/

European Medicines Agency (EMA) manage medicinal product procedures (as yet limited device involvement) http://www.ema.europa.eu/ema/ Committee of Human Pharmaceutical Products (CHMP) provide scientific assessment with the support of specialised working groups

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National Regulatory Agencies

Some countries have one agency that implements both medical device and medicinal product legislation e.g. Ireland

Others have different agencies e.g. Netherlands

Netherlands: Devices: Health Care Inspectorate (IGZ)

Netherlands : Medicines: Medicines Evaluation Board (MEB)

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