Medical device Common Technical Document (CTD) application. US and EU

 The Common Technical Document (CTD) is a standard format for presenting data in an Investigational New Drug (IND) application to the FDA


Includes a good Graphic. How to handle your Medical Device Technical Documentation? – Part 1: Basic definitions https://www.debiotech.com/how-to-handle-your-medical-device-technical-documentation-part-1-basic-definitions/



From FDA : 

(a) Electronic Common Technical Document (eCTD) https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd

(b) Guidance document. FAQs. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m4-ctd-general-questions-and-answers

Ref

https://www.bioduro.com/news-resources/insights/common-technical-document.html#:~:text=The%20Common%20Technical%20Document%20%28CTD%29%20is%20a%20standard,ensuring%20consistent%20and%20comprehensive%20information%20for%20regulatory%20review.


Additionally:

How to CE Mark a Medical Device that Incorporates a Drug

https://medtechintelligence.com/feature_article/how-to-ce-mark-a-medical-device-that-incorporates-a-drug/

For EU https://clin-r.com/eu-mdr-how-to-structure-your-medical-device-technical-document/

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