Webinar
Medical Devices

MDR Annex XVI devices without an intended medical purpose

A summary of the device types covered under Annex XVI (EU) 2017/745 and Common Specification 2022/23/48.

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Learn about Annex XVI (EU) 2017/745 & Common Specification 2022/23/48.

Different transition provisions, routes to conformity including CECP requirements & differences in classification for active Annex XVI devices.

MDR Annex XVI Requirements/ Scope.
Groups: Descriptions and Examples.
Common Specifications.
Transition Provisions & Conformity Considerations.

MDR Annex XVI devices without an intended medical purpose

This webinar will provide attendees with the latest BSI knowledge on Annex XVI.

Neill Bannister, Global Head, General Devices Team, BSI

Nick Trilokekar, Ph.D, Team Manager, General Devices Team, BSI

Insights & Media

Find out about the latest quality trends with insights from our experts

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Maintaining Compliance IVDR post certification activities

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Annex XVI devices without an medical purpose for dermal fillers

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Ensuring trust and conformity of AI enabled Medical Devices

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Extension to IVDR transition timelines webinar

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Amending Regulation (EU) 2023-607 and possible pitfalls

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Medical Device Lifetime

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