Team NB's Best Practice Guidance v3, Explained
Team-NB has rolled out Version 3 of its Best Practice Guidance for the Submission of Technical Documentation under MDR (EU) 2017/745. This updated edition, which is a huge 79 pages, further develops the Notified Bodies (NBs) expectation and requirements for clear, consistent and compliant Technical Documentation (TD).
The main thing that stood out to me in this guidance was that of claims.
This document goes way more into claims management than many others (if not all) other than the MDR itself. However, the role of claims as we know applies to all economic operators such as importers and distributors - section 2.8 of the document specifies:
Only marketing literature that mention that the device fulfils the requirements of CE marking or includes the CE mark itself is required to be provided” followed by
Supporting evidence should be provided in the relevant pre-clinical and clinical sections to substantiate any claims made in the labelling or marketing literature.
So when we apply the understanding that we know article 7 contains a prohibition so it applies to all economic operators, therefore even economic operator material must be supplied if it meets this criteria.
Manufactures can ready their importers and distributors for example under their role of Article 13 and 14 respectively by providing them with a sample register for example, providing the basis for a contractual agreement and having an introduction/training workshop if required to align distributors to the regulatory expectations. Or they can find someone that already knows what needs to be done.
This will also require to be reflected contractually to allow you to have some enforcement power as the “legal manufacturer”.
Do you not think it’s weird that term still doesn’t exist in a legislative format so far for MDR or IVDR? I think it is so weird.
Updates from v2 to v3
I’ve tried to keep things really concise here and give a brief overview of some changes in the document as it is pretty summarised in the guidance.
You can find the full guidance here of course - https://www.team-nb.org/team-nb-position-paper-on-best-practice-guidance-for-the-submission-of-technical-documentation-under-annex-ii-and-iii-of-medical-device-regulation-eu-2017-745-v3/
1. Streamlined Structure & Expanded Content
Version 3 is a major expansion from the 47-page Version 2 to 79 pages.
2. Pre-Submission Communication (Page 4)
Manufacturers are now encouraged to engage in structured dialogue with their notified body. Reference to MDCG 2019-6 outlines expectations around early engagement.
3. Enhanced Submission Structure (Page 5)
Emphasis on organised, searchable documentation with hyperlinks.
Guidance includes tips on folder structure and translation quality control.
4. Device Description Deep Dive (Page 8)
Now requires EMDN, MDA/MDN/MDS codes and details on device function principles. Explicitly mandates stating whether the device has novel features, or affirming if it doesn't.
5. Material Disclosure & Specifications (Page 12)
New expectations around CAS numbers, nanomaterial identification, and coatings.
6. Accessory & Product Compatibility (Page 11)
Detailed classification rationale for accessories, Inclusion of non-device products and their compatibility evidence.
7. Electronic IFUs Expanded (Page 15)
Compliance with EU Regulation 2021/2226 is now clearly outlined.
Requirements around access, updates, and language versions have been clarified.
8. Common Pitfalls (Page 13+)
New sub-sections call out frequent errors in submissions, from incorrect UDI assignments to misused terminology, to risk management issues and more.
9. Abbreviation Reference Added (Page 7)
Over 40 key terms now listed to standardise language and reduce ambiguity.