There are a number of ways to compile Technical Documentation for CE Marking and Health Canada, but note that you should reference any current use methods. As an example, Health Canada is going away from STED and will use the IMDRF RPS structure. As Vidya indicated BSI has a structure which they want to have bookmarked, which loosely follows STED. But regardless whether you follow STED or RPS structure, there is much more content contained in the regulatory submission that is not covered by either the STED or RPS inclusively. If you intend to create a singular Technical Document file structure, would recommend you spend some time looking at STED, RPS, the BSI guidance (if you indeed use BSI otherwise you should inquire with your own NB on their expected structure), and Health Canada guidance to compile a singular file that will meet all of the requirements. It might be able to be done, but can be difficult because the content for each are slightly different. That is why IMDRF created the RPS, though it is unfortunate it is not more detailed because using a "one submission" approach needs to be more detailed, hopefully some of the further guidance from IMDRF will get more detailed and sometime in the near future we can indeed have one submission for multiple countries.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 11-Apr-2019 09:41
From: Vidya J
Subject: Technical File: Class IIa Devices EU / Class III Canada
I would think so. I prefer the pdf guidelines because it covers both content and submission instructions and also makes references to STED guidance.
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Vidya
USA
Original Message:
Sent: 10-Apr-2019 21:37
From: Julie Omohundro
Subject: Technical File: Class IIa Devices EU / Class III Canada
I think the BSI format may follow the same format as the MEDDEV?
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 10-Apr-2019 10:44
From: Craig Jolicoeur
Subject: Technical File: Class IIa Devices EU / Class III Canada
Hi
I am revising our Technical File for a Class IIa family of products in the EU that are Class III in Canada. I would like to have one file for this family that covers the EU and Canadian TF requirements.
My initial though was to revise to BSI's "Medical Device Documentation Submissions Best Practice Guidelines
https://www.bsigroup.com/globalassets/meddev/localfiles/ja-jp/documents/bsi_best_practice_guidelines.pdf
or NB-MED/2.5.1/Rec5 Technical Documentation
or other?
any thoughts on which way to go...?
Thank you in advance,
Craig
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Craig Jolicoeur CQE
Quality and Regulatory Manager
San Marcos CA
United States
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