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Course Details

MDR Annex XVI devices without an intended medical purpose

Student taking online training

Course Area

Medical Devices

Availability

Available for 90 days after enrollment

Approximate Course Run Time

1 hour

Continuing Education Units

0.1

Course Fee

No charge

E-learning content is available on demand

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Course Details

Overview

After a summary of the device types covered under Annex XVI (EU) 2017/745 and Common Specification 2022/23/48, the webinar will clarify the different transition provisions for these types of devices, the routes to conformity including CECP requirements and differences in classification for certain active Annex XVI devices.

Key takeaways and learning objectives

Join the webinar to:

  • Explore the types of devices covered under Annex XVI and the transitions provisions for these types of devices.
  • Understand the route to conformity including CECP requirements and differences in classification for certain active Annex XVI devices.

Presenter information

Speaker - Neill Bannister, Global Head of General Devices, Regulatory Services, BSI

Speaker -Dr. Nick Trilokekar, Technical Team Manager, General Devices, Regulatory Services, BSI

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