Module 15 Presentations

4/15/2024

Regulation Governance

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Medical Device Co-ordination Group (MDCG)

• Responsibilities (Article 105 and 106) • Contribute to assessment of notified bodies and input into other notified body-related activities; • Contribute to assessment of effectiveness of the GSPRs • Contribute to development of CS and other scientific guidance; • Assists CAs in their coordination activities in particular, in the fields of classification and the determination of the regulatory status of devices, clinical investigations, vigilance and market surveillance • Provision of scientific, technical and clinical opinions and advice • Expert panels • Expert laboratories • Advice or guidance on implementation of the MDR, and support harmonised processes in member states.

• https://ec.europa.eu/growth/sectors/medical-devices/guidance_en

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© NAMSA 2021

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