Essentials of European Medical Device Regulatory Affairs - June 2020

Chapter IV

Articles 35-50

Notified bodies

Who’s who? Key Stakeholders

RegulatoryAgencies – CompetentAuthorities

Notified Bodies

European committees and organizations

TheOrganisation for Professionals in 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/ MDR responsibility moved from DG Health to DG Sante Jan 2020

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

TheOrganisation for Professionals in Regulatory Affairs

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)

TheOrganisation for Professionals in Regulatory Affairs

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