MDR technical file submission: what manufacturers really need to take care of (Team-NB, April 2025)

News

09 April 2025

1. A long-awaited guide, now a must

Regulation (EU) 2017/745 imposes a clear requirement on medical device manufacturers: to demonstrate compliance with general safety and performance requirements (GSPR) through a structured and comprehensive technical dossier. But in practice, what do you really need to provide? And how can we avoid the pitfalls that lead to delays?

Version 3 of the Team-NB guide, published in April 2025, provides concrete answers to these questions. Based on feedback from several European Notified Bodies, this document has become a benchmark for manufacturers and their partners. It provides practical recommendations, warns of frequent errors, and clarifies what is expected of assessors.

2. What this guide means in concrete terms for manufacturers

This guide does not create any new obligations, but it does make explicit what notified bodies really expect from a well-constructed technical file. The most striking recommendations include

Structural clarity: the dossier should be easy to navigate, with a hyperlinked table of contents, precise cross-references and total consistency between sections.
Language: it is advisable to clarify very early on with the notified body the language expected for submission. Poor translation = guaranteed delays.
Justifications required: every deviation from the state of the art, every standard partially applied, every piece of old data reused must be justified.
Avoid a mere accumulation of reports: traceability between identified risks, control measures and associated verification/validation tests must be demonstrated.

Key requirement: the file must demonstrate how each GSPR is met, with evidence, method of demonstration, standard applied, and supporting documentation. Not just an empty table with crosses.

Data recycling: what's (still) acceptable

The guide authorizes the use of data from the MDD assessment, provided it is still relevant and the requirements have not changed. In this case, it must be clearly stated :

what has already been assessed by the NB,
what has changed since then
and whether the data is still valid according to the state of the art.

Table - Reuse of MDD data

Data	Conditionally reusable?	How to justify?
Biocompatibility reports MDD	✅ Yes	Gap analysis ISO 10993-1
Sterilization validation	✅ Yes	Identical process + validation still up to date
Clinical data on equivalent	⚠️ Subject to	Prove access to technical file + demonstrate equivalence (MDCG 2020-5)
Old GSPR checklist (under MDD)	❌ No	Completely redo according to MDR Annex I requirements

3. The most common mistakes: what NBs no longer forgive

The guide identifies the most frequent pitfalls encountered by technical assessors. Here are some of the most critical:

Inconsistent intended use between IFU, SSCP, CER, DoC..
IFU too generic, with contraindications absent or unjustified.
Rationales unclear or absent for choice of standards, methods, materials.
Clinical equivalence poorly documented, particularly for software.
Lack of justification for GSPRs declared "not applicable".
Clinical risks poorly integrated into the RMF (the link with clinical validation must be obvious).

MDR Pre-Submission Checklist - 10 points to check before sending to the NB

1.Consistency of intended use

Exact alignment between IFU, GSPR, CER, SSCP, DoC, labeling.
Definitions comply with MDCG 2020-6 (do not confuse indications and intended use).

2.Clear, navigable file structure

Hyperlinked table of contents, clear versioning, structured index.
Documents explicitly named and time-stamped.

3.Complete and justified GSPR checklist

For each requirement: applicable / not applicable + demonstration method + standard + documentary evidence.
Solid justification for any non-harmonized or partially applied standard.

4.Full clinical documentation

Up-to-date CER, compliant with annexes XIV + MDCG 2020-6 + MEDDEV 2.7/1 rev.4.
Robust data, equivalence duly demonstrated if claimed.
Clinical claims all traced to real evidence.

5.Risk controlled AND traceability assured

Each risk identified → control → verification → validation → proof.
RMF aligned with clinical data, GSPR, IFU.

6.Validated translations (if applicable)

Language compliant with NB requirements.
Translations available or planned for all marketing languages.

7.Clear, realistic and documented PMCF plan

Objectives, methods (general/specific), monitoring indicators.
PMCF report (if available) integrated with CER.

8.Reused data properly justified

Gap analyses for biocompatibility, sterilization, equivalence, etc.
MDD reports reported and contextualized.

9.Complete validation documents

No partial reports or protocols alone.
All critical tests versioned and identified (V&V design, sterilization, shelf-life, etc.).

10.Global alignment with regulatory classes and obligations

Documentary checklist for each class respected.
PSUR/SSCP well planned according to DM type.

Print out this checklist and tick off each point once validated. A good dossier is 50% technical work and 50% rigorous documentation.

4. Focus: 3 chapters of the guide that you must read (even if you delegate)

A. GSPR Checklist (Appendix I MDR)

This is the backbone of the file. The guide emphasizes :

The importance of rationalizing each deviation (e.g. if a standard is only partially applied).
The need to cross-reference each requirement with documented evidence precisely located in the file.
The inadmissibility of unclear or unversioned tables.

B. Clinical assessment (REC + plan)

The guide offers a welcome synthesis of MDR + MDCG + MEDDEV requirements:

The clinical evaluation plan (CEP) must be aligned with the declared purpose.
Databases, inclusion criteria and statistical analyses must be rigorously justified.
Proof of access to the equivalent file is mandatory for class III implantable devices.
Each marketing claim must be traceable to a clinical dataset.

For software devices: consider alignment with MDCG 2020-1 + proof of clinical validity, technical performance, clinical performance.

C. PMCF and PSUR

Section 6.3.4 is a gold mine:

Every device must have a PMCF plan, even if there is no specific study.
Objectives must be clear, realistic and traceable.
The SSCP must synthesize the data and derive actions from it (updating the CER, RMF, etc.).
SSCP expectations are very precise (format, frequency, language, patient version, etc.).

Table: Summary of required documents by class (see page 51 of the guide)

* Literature search protocols and reports, covering the objectives of systematically assessing the state of the art and identifying all available clinical data supporting the device under evaluation, can be provided as stand-alone documents or integrated into the Clinical Evaluation Plan (CEP) or Clinical Evaluation Report (CER).

A full copy of the relevant articles should also be attached.

** The PMCF report can be provided as a stand-alone document or integrated into the Clinical Evaluation Report (CER).

5. Two case studies

Case 1 - Experienced manufacturer, but file rejected

A Class IIb manufacturer submits a dossier for a device with a robust private label history. But :

The IFU presents an "intended use" different from the CER.
Clinical equivalence is declared without proof of technical access.
The PSUR is devoid of any action, despite a vigilance alert on a component.

Verdict: assessment suspended. Resumption after 5-month review.

Case 2 - SaMD start-up: success on the 1st try

A start-up submits a software DM:

Perfect traceability between specifications, GSPR requirements, risks and validation tests.
Structured file with hyperlinked table of contents.
Well-dimensioned PMCF with planned level 4 user survey.

Result: a smooth evaluation, with no major issues.

6. Mini FAQ

Can I submit a partial test report?

No, the guide clearly states that only complete, dated and versioned reports are accepted.

Is an English IFU sufficient for initial submission?

Yes, if the NB accepts it (to be validated beforehand). But all marketing languages must follow.

Is SSCP required?

Yes, for all class III and implantable devices. Even if not yet on the market.

Does everything have to be translated for the NB?

Not necessarily, but abstracts/critical extracts must be. Check NB policy.

PMCF: when should the NB be notified of a change?

As soon as there is a significant change (objectives, method, schedule, etc.). To be anticipated.

7. What CSDmed can do for you

Submitting an MDR dossier is not about "just filling in the blanks".

It's about rigorously and strategically demonstrating that the system is safe, effective and under control.

It also means anticipating objections, speaking the language of the notified body, and making the right methodological choices.

CSDmed supports manufacturers in this demanding process:

Critical review of your technical files
Help with document structuring and consistency
Strategic support in the pre-submission phase

Write to us: every day gained in evaluation is another day gained on the market.

8. Related resources

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