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Webinar live
18 GEN 2024

Borderline medical devices

Regulatory and classification issues in Europe, according to version 3 of the borderline manual and to MDCG 2022-5 guideline

Online 10:00 AM - 11:00 AM CET

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A "manual on borderline and classification for medical devices" is a comprehensive document with collection of regulatory decisions by competent authorities in Europe that provides detailed information and guidelines for regulatory professionals, manufacturers, and other stakeholders in the medical device industry. this manual aims to assist individuals and organizations in understanding and correctly classifying medical devices, particularly in cases where the categorization is not straightforward and falls into a "borderline" category.

This webinar would provide an overview of the complex issues surrounding medical device classification, including borderline cases.

The webinar will start handling definitions and concepts that are used during the classification process including definitions of pharmacological, immunological, metabolic means and of principal mode of action, passing through the possible drug/device combinations and the actors involved in the management of the different cases to finish with practical examples related to the manual on borderline and classification for medical devices under  regulation (EU) 2017/745  version 3 – September 2023 with references to MDCG 2022-5 too.

Our webinar will tackle these points, focusing on:

  • regulatory overview
  • consultation of regulatory authorities or experts:
  • updated definitions of pharmacological, immunological, metabolic means
  • the concepts of “a substance considered a medicinal product” and “action ancillary to that of the device”
  • medical device and medicinal product combinations, different scenarios and players involved
  • qualification and classification of medical devices
  • borderline cases
  • Q&A

SPEAKER

Fabio Magnani, Senior product specialist, non-active medical devices lead auditor and technical documentation Assessor TÜV SÜD

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