Module 18 2021

07/02/2021

Learning Outcomes

To understand and describe: ● Devices incorporating ancillary medicinal substances ● The role of Notified bodies and Medicines CAs ● The regulatory process for assessment of DDCs ● Post-consultation requirements ● Borderline and classification issues ● MDR related uncertainties

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Acknowledgements

Janine Jamieson BSi TUV Sud

helen@espl-regulatory.com

Thank you! Questions ??

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