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Course Details

Clinical evaluation under the MDR webinar

Course Area

Medical Devices


Available for 90 days after enrollment

Approximate Course Run Time

1 hour

Continuing Education Units


Course Fee

No charge

E-learning content is available on demand


Course Details


Understanding of the clinical evaluation process for medical devices against the requirements of the Medical Device Regulation (MDR – (EU) 2017/745), MEDDEV 2.7/1 Revision 4, and relevant Medical Device Coordination Group (MDCG) guidance documents is now critical for all manufacturers.

Key takeaways and learning objectives

  • The clinical evaluation process at BSI and the clinical team involved.
  • Critical areas of the Clinical Evaluation Report (CER) along with some expanded information about what notified bodies expect to see under the MDR.
  • How to present ‘State of the Art’ for your submission. 
  • Critical points for the additional documentation required under MDR and how these documents affect manufacturers and where they should fit into their document cycle: Summary of Safety and Clinical Performance (SSCP), Periodic Safety Update Report (PSUR) and Clinical Evaluation Assessment Report (CEAR).The main messages from updates including coverage of MDCG 2019-9, MDCCG 2020-7, MDCG 2020-8, and MDCG 2020-13.

Presenter information

Join this webinar to hear Richard Holborow, Global Head of Clinical Compliance for BSI.

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Private Class

Interested in a private or customized version of this course? Request a quote.


For questions regarding any of our courses, contact us or call 1.800.217.1390.


For questions regarding any of our courses, contact us or call 800.217.1390 (USA) 800.862.6752 (Canada)

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