Informational MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019

[Marcelo]

MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019

Posted at Marcelo's Medicaldevice.expert website...

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[Wolf.K]

There is a new version (Rev. 1.1) from March, 2022.

I have a question regarding this guidance document. What is meant with "Summary of study methods"? If the kind of surgery (e.g.) is meant, is this not already included within the other topics in the listing?