Regulatory Open Forum

Hi, I would like to know if there are any websites that provide step to step guidance and templates for Technical Files and CTD preparation.? 

Thank you.!

For medical device Technical Documentation under the EU MDR, the required format is fashioned after the GHTF STED format.  Accordingly, you may want to visit the IMDRF website for guidance on that.  You can also purchase a template from an expert third party (feel free to contact me or others offline for that).

For the U.S. FDA, submissions (such as drug submissions) that are required to be in CTD format are generally required to be in electronic (eCTD) format.  There are options around for eCTD creation and publication software that can be purchased. 

Hi, I would like to know if there are any websites that provide step to step guidance and templates for Technical Files and CTD preparation.? 

Thank you.!

Anon,

Technical documentation file structure for the European Union (and some other countries) are typically by the IMDRF/GHTF structure for STED https://www.imdrf.org/sites/default/files/docs/ghtf/archived/sg1/technical-docs/ghtf-sg1-n063-2011-summary-technical-documentation-ivd-safety-conformity-110317.doc or RPS https://www.imdrf.org/working-groups/regulated-product-submission.  There are much more intricacies to developing technical documentation, so might also want to seek some expert advice depending on where you are planning your submission.

The CTD structure for pharmaceutical submissions is commonly only accepted in eCTD now; there are external companies which provide some off-the-shelf solutions rather than creating on your own.  It can be done, but also is a lot of work.

For medical device Technical Documentation under the EU MDR, the required format is fashioned after the GHTF STED format.  Accordingly, you may want to visit the IMDRF website for guidance on that.  You can also purchase a template from an expert third party (feel free to contact me or others offline for that).

For the U.S. FDA, submissions (such as drug submissions) that are required to be in CTD format are generally required to be in electronic (eCTD) format.  There are options around for eCTD creation and publication software that can be purchased. 

Hi, I would like to know if there are any websites that provide step to step guidance and templates for Technical Files and CTD preparation.? 

Thank you.!

For medical device Technical Documentation under the EU MDR, the required format is fashioned after the GHTF STED format.  Accordingly, you may want to visit the IMDRF website for guidance on that.  You can also purchase a template from an expert third party (feel free to contact me or others offline for that).

For the U.S. FDA, submissions (such as drug submissions) that are required to be in CTD format are generally required to be in electronic (eCTD) format.  There are options around for eCTD creation and publication software that can be purchased. 

Hi, I would like to know if there are any websites that provide step to step guidance and templates for Technical Files and CTD preparation.? 

Thank you.!

Hi, I would like to know if there are any websites that provide step to step guidance and templates for Technical Files and CTD preparation.? 

Thank you.!

Hi Anon,

for the EU MDR Technical Documentation the main content required is given in Annex II (and for post-market documentation in Annex III). This is not directly a fixed table of contents but usually a good starting point. I assume there are several websites that offer templates based on these requirements. If you need a Notified Body for your conformity assessment it usually makes sense to see if they have any preferred format (e.g. mdc gives templates here).

Best regards, Christoph

Hi, I would like to know if there are any websites that provide step to step guidance and templates for Technical Files and CTD preparation.? 

Thank you.!