How to Structure Technical Documentation

Technical documentation for the MDR must not only comply with Annexes II and III, but also be easily accessible to the product assessor. A disorganized structure or hard‑to‑find information leads to delays, nonconformities, and wasted time—especially with the upcoming MDD deadlines. The Team NB guideline on the submission of technical documentation provides a valuable reference: the main causes of delays are incomplete files and lack of structural coherence. Avoid non‑searchable PDFs, unusable tables of contents, and duplicated information; instead, ensure data completeness (including raw test data) and consistency of key elements such as the intended use and the Basic UDI‑DI. When documents are updated, changes must be clearly highlighted and described within the quality system. Responses to findings must be complete and self‑contained, and subsequent submissions must include the entire technical file, not just the modified sections. Translations must be accurate and professional. It is also essential to review the specific regulations of the Notified Body, which may include additional mandatory requirements. Finally, it is possible to request a structured dialogue with the Notified Body for procedural clarifications. In short: making the product assessor’s job easier ultimately makes your own work easier.

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Welcome to Compliance Espresso, the podcast where we break down European medical device legislation with clarity, rigor, and just a hint of irony. Short episodes designed to give you reliable guidance in just a few minutes, like a good cup of coffee. I'm Nicola Focci. I've been working in the medical device field for over 25 years, including 8 years inside notified bodies. Let's get started. Let's not beat around the bush. The technical documentation submitted to the notified body must of course meet the requirements of annexes 2 and 3 of the MDR, but it must also be understandable for the product assessor who has to review it. Believe in someone me who has held this role in the past. After all, what do you do when you receive an incomprehensible gas or electricity bill and you try to find a specific piece of information like your monthly consumption, but you can't, because it's buried under a mountain of other data? You get annoyed, right? Don't annoy the product assessor. Not because they delicate souls, but because it will cost you time later. And with the MDD deadlines approaching fast, there's no time to waste. So put yourself in the assessor's shoes and evaluate your technical documentation from the perspective of evidence accessibility. We had a rule: if it takes more than 3 minutes to find something right and on conformity, it's very likely your product assessor will think the same way. If you need a solid reference on how to properly structure technical documentation full of practical tips, I recommend the Team MB guideline Best Practice Guidance for the Submission of Technical Documentation under Annex 2 and 3 of Medical Device Regulation. It's easy to find with a simple online search. The document was drafted by notified bodies, I personally took part in the founding working group to help manufacturers prepare a technical file that is organized, complete, and effective. Unsurprisingly, the guideline identifies the two most common cases of delays in assessments as first submitting incomplete documentation, second, lacking of a consistent structure. The information exists but is hard to locate. Avoid not searchable PDFs, for example, fully scanned documents. I remember a manufacturer submitting 1500 pages of non-searchable files with a table of contents that did not include page numbers. It was a nightmare, the kind that gives you carpal tunnel syndrome from scrolling just to find what you need. Pay close attention to completeness. If a supplier sends you a summary test report without raw data, expect a finding. Prevention is always better than cure. And don't be fooled by confidentiality excuses. The notified body is required by its own regulatory obligations to maintain confidentiality and integrity of all information received so your data is safe. When you revise the technical file, make it immediately clear what you changed and why. Make the assessor's job easier. Don't fall into the trap of thinking that making their work harder will make them more lenient. They'll simply issue more non-conformities because they can't understand what they are reading. Choose any system you like, underlining, sidebars, color coding, but highlight your changes and document this practice in your quality management system. When responding to findings, write as if the recipient were reading that report for the very first time. Don't take anything for granted. Better one repetition too many than one concept too few, because the burden of proof is up to you. When you send a technical documentation in response to findings, always send the entire technical file, not just the modified sections. Otherwise, you risk compromising the integrity of the documentation on the notified body's side, which is never a good thing for either party. If you need to translate the technical documentation, because the notified body requires a different language, do it carefully. No need to explain why, but don't rely on crude online translation tools. Otherwise, at best you'll waste time with back and forth questions and clarifications. Watch out for duplicated information. There's plenty of it. For example, the intended use and the basic UDIDI may appear multiple times in different sections of the technical file. Be consistent. Always double-check that these elements are reportedly identically. Use your WordPressor search or bookmark function to quickly jump to the relevant sections. One last tip carefully review the notified body's own regulations before submitting your documentation. They are always available on the notified body's website. These documents often contain additional requirements, such as language requirements, that are contractual and therefore mandatory. And don't forget, you can always request a structured dialogue with the notified body. This is not consultancy, which the notified body cannot provide, but clarification on regulatory procedures, which the notified body is obliged to give. It is provided for in the MDR itself, Annex 7.129, theoretically at no additional cost as stated in MDCG 2019 6. The important thing is to avoid asking how do I become compliant? Because that is consultancy and the notified body cannot answer. In short, help the product assessor to help you. Put them in the best possible position to do their job and everything will run smoothly. You've just listened to an episode of Compliance Espresso. The next episode will be out in two weeks. If you have comments or suggestions, feel free to write me at nicola at focci.it. Thank you for listening.