Team-NB’s New MDR Guidance — How meddevo Makes It Work in Practice

In April 2025, Team-NB, the European Association of Medical Devices Notified Bodies, published Version 3 of their best practice guidance on technical documentation under the EU Medical Device Regulation (MDR) 2017/745. At 79 pages, it’s not light reading, but it’s essential. This is not a one-time guide to skim and forget; it’s a comprehensive resource you’ll want to return to repeatedly throughout the lifecycle of your medical device submissions.

The central theme? Consistency.

Again and again, the guidance points out that lack of consistency across documentation — whether in terminology, formatting, traceability, or data — is one of the primary causes of delay, confusion, and even rejection during conformity assessments. When the paper says things like:

“Ensure there is 1:1 alignment across all the information provided, do not let the SSCP deviate from the IFU or the patient information leaflet.”

— you can almost feel the pain of the auditor who had to write that. This isn’t a casual reminder, it’s the weary frustration of someone who’s reviewed one too many SSCPs that say something different than the IFU, or found inconsistencies that could’ve been avoided with a single source of truth.

Let’s be honest: who hasn’t updated the intended use in the shiny new IFU.. only to forget the same wording appears three other times, in three other files, in three different folders? The result? Extra rounds of questions, review delays, and a frustrated auditor muttering into their checklist.

This is the exact challenge we’ve built our solution to solve. meddevo is designed around a Single Source of Truth — which means that all documents and components in your technical file pull their data from one central, authoritative place. If you update a field like intended use or classification in that data core, the change automatically propagates across all connected documents: the GSPR checklist, the IFU, the SSCP, the DoC, and more.

No more duplicate edits. No more version mismatches. No more forgetting that a change in the labeling must also reflect in the risk file.

And because every component is linked back to this shared dataset, everything stays consistent — not just in theory, but in practice, even across formats and departments. That’s not just a productivity win; it’s a way to meet the exact consistency standards that Team-NB is calling for.

The Industry’s Core Problem: Consistency Takes Time (and Sanity)

The paper states:

“Inconsistencies are observed within the various documentation...”
“Ensure there is 1:1 alignment across all the information provided…”
“Information must be correct throughout all areas where this information is duplicated…”

Maintaining that level of alignment manually is exhausting and error-prone. Most organizations rely on disconnected Word docs, Excel sheets, and endless folders — and Team-NB sees the results every day.

Our Take: Consistency Can Be a Nightmare — or a Feature

We believe that consistency shouldn’t be a burden — it should be built-in.

That’s why we designed our platform around a Single Source of Truth:

• One change to intended use or classification cascades through the GSPR checklist, IFU, DoC, SSCP, and clinical evaluation.
• Evidence and reports are version-controlled and traceably linked.
• Our system prevents common pitfalls: conflicting data, missing links, misaligned labels.

With our tools, teams can focus on strategic work — not on policing formatting or chasing down contradictory definitions.

A Deep Dive into the Structure of the Guidance

The document is not a casual overview, it’s a full blueprint of how to prepare every single part of your technical documentation under Annex II and III of MDR 2017/745. Rather than offering abstract principles, it walks through each required section step by step and provides practical expectations, recurring issues, and recommendations from the perspective of the auditors themselves.

The result is a detailed, highly usable guide — one that regulatory  teams will inevitably return to again and again — not just as they prepare submissions, but whenever they need clarification while working through different MDR chapters. It’s not a document to read once and shelve; it’s a practical companion for the entire documentation journey. Beyond acting as a structured checklist and guide, it provides valuable regulatory insight and serves as a reliable point of reference whenever uncertainties arise in interpreting or applying specific MDR requirements.

Key Messages from the Team-NB Guidance - and how meddevo can help you address those

Structured Submissions

“Lack of Cohesive Structure of Technical Documentation - The information is presented within the Technical Documentation but is difficult to locate.”

Our system ensures structure that’s review-ready, no matter which regulatory framework you're working within. Since international requirements for technical documentation structure differ, meddevo provides a range of predefined folder structures via our "Folder Preview" function. Whether you're building a file for a product, product group, or full eTD, our templates (e.g., "EU-MDR ANNEX II" or "US-FDA") automatically sort scoped documents into the appropriate folders.

Need to switch from MDR to FDA submission? No problem, the system automatically sorts the documents into the next structure whenever necessary.

This not only brings your submission into the expected format of the target authority, but also saves hours of manual sorting. In addition to our predefined structures, you also have full flexibility: you can modify or create your own structural templates to match the unique needs of your product or internal processes. This way, meddevo doesn’t force you into a rigid system — it gives you a strong starting point and the freedom to adapt it to your workflow, while still staying aligned with regulatory expectations.

Data Consistency

“Ensure the data in the technical documentation is consistent with the data provided in the respective application forms.”

We link your data across documents — one source, zero mismatch. But more importantly: in meddevo, documents as you know them are a thing of the past. We don’t work in static documents anymore, we work in databases. You define the structure of your documents once, by building document templates, and from there, everything is data-driven.

Need an updated IFU? Or a new GSPR checklist? Our system generates those documents automatically, based on the templates you’ve set up and the data you’ve entered. There’s no manual formatting, no copy-pasting between files, no worrying whether your latest change was reflected in every instance.

Of course, we provide a library of predefined templates — all structured around the latest regulatory expectations. Right now, we’re actively reviewing and aligning those templates against every requirement outlined in the new Team-NB position paper. But meddevo doesn’t lock you in: you can use our templates as they are, adapt them to your processes, or build entirely new ones from scratch. Full autonomy — with structure, intelligence, and compliance built in.

Avoiding Hidden Gaps Before Your Reviewer Finds Them

“The most common reasons for delays in Technical Documentation assessments by notified bodies are : Insufficient or missing information not provided that is required for the conformity assessment activities.”

We help you prevent these gaps long before your submission reaches a reviewer. One of the most common causes of delay, as Team-NB highlights, is missing or incomplete content that’s essential for conformity assessment — and too often, it’s simply overlooked. That’s where our Inspector comes in: it constantly monitors your technical documentation database to detect gaps in real time. Whether it's a forgotten justification, an empty required field, or inconsistent data, the Inspector alerts you immediately.

This means you’re always working with a live, up-to-date view of your documentation’s compliance status. It’s like having a built-in auditor that flags issues before your Notified Body ever sees them — helping you avoid the most frustrating kind of feedback: the “you forgot something” kind.

Big Picture: A Shift Toward Smart Submissions

The message from Team-NB is clear: Regulatory documentation needs to evolve.

They want submissions that are:

• Transparent
• Justified
• Cross-referenced
• Consistent

We’ve been ahead of the curve — and we’re ready to help more teams join us.

Where Human Expertise Still Matters

Of course, meddevo doesn’t take all the work off your shoulders. Some elements still require sound expert judgment — and rightly so. For instance, the Team-NB paper notes:

"Rationales for various definitions and classifications are not detailed enough: For example, for devices including a drug substance, justification is not included as to why the drug substance is considered ancillary to the mechanical action of the device."

While meddevo can provide the right database structure and templating tools to store and reuse such justifications in the correct context, the responsibility for crafting thorough, scientifically sound rationales remains with your team.

That said, you’re never left entirely on your own. Your primary contact at meddevo will be a regulatory expert themselves and can help when you need a sparring partner to talk through complex topics or a second opinion to validate your thinking. And if your question goes beyond our own scope, we’re well connected in the regulatory community and can point you to trusted consultants who specialize in exactly what you need.

We take the tedious, repetitive document work off your shoulders, so you can focus your expertise on the real regulatory questions that matter.

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