Essentials of European Medical Device Regulatory Affairs

MDCG Publications

• A range of guidance documents to assist stakeholders in implementing the medical devices regulations • Legally non-binding guidance documents, adopted by the medical device coordination group (MDCG) in accordance with Article 105 of Regulation 745/2017 • Objective of ensuring uniform application of the relevant provisions of the regulations within the EU • https://ec.europa.eu/growth/sectors/medical- devices/new-regulations/guidance_en

The Organisationfor Professionals inRegulatory Affairs

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Module 2

Key Stakeholders – Regulatory Agencies – Competent Authorities – Notified Bodies – European Commission and Committees

– Legal Manufacturer – Economic Operators

The Organisationfor Professionals inRegulatory Affairs