Module 18 2021

05/02/2021

Module 18: Drug Device Combinations and other Technology

Notified Body Role & Expectations for DDCs

Theresa Jeary, Medicinal & Biologics Team, BSI

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Learning Outcomes

• What is a Notified Body • Role of the NB for Devices with ancillary medicinal products • Types of products • Process • Role of NB under MDR Article 117 • Background to change • Notified Body involvement & feedback on process so far

The Organisation for Professionals in Regulatory Affairs

Module 18: Lecture 11 Theresa Jeary 10 February 2021

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