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Course Details

Amending Regulation EU 2023 607 and possible pitfalls

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 (EU) 2023/607 content, the webinar will clarify what are the responsibilities of manufacturers.
We will then explore the potential impact on legacy devices of non-compliance with (EU) 2023/607 conditions and in case of MDR certification refusals.

Key takeaways and learning objectives

Join the webinar to:

  • Explore what are the responsibilities of manufacturers in the context of (EU) 2023/607.
  • Understand the impact of non-compliance with (EU) 2023/607 conditions in respect to legacy devices and in case of MDR certification refusals.

Presenter information

Speaker -  Maddalena Pinsi, Senior Regulatory Lead & Associate Head of Medical Devices Notified Body

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