MDR technical file review: have it challenged before the Notified Body does.
A critical, platform-powered review of your technical file before it goes to the Notified Body or, for self-certified devices, before placing on the market. One round trip avoided often means six months saved.
Initial scoping is free, with no commitment. All classes, from class I to implantables.
What you get
- Completeness of the general requirements (GSPR)
- Compliance with applicable standards
- Overall consistency of the file
- List of blocking points
Good to know
- All classes, from class I to class III and implantable devices, where an independent review matters most
- Scope confirmed after scoping, depending on the class and the size of the file
Ideal if: this is your first MDR submission, nobody has challenged the file from the outside, or you are placing a class I device on the market without going through a Notified Body.
What a round trip costs you
An incomplete or inconsistent technical file does not get you a rejection. It gets you a request for additional information, which is often worse.
The file comes back to you, you respond, and it goes back into the Notified Body's queue. With current assessment lead times, each cycle is measured in months, not weeks. Meanwhile the product is not on the market, the team stays tied up, and the commercial plan slips accordingly.
The cause is rarely a glaring error. It is almost always an inconsistency: a general safety and performance requirement that points to missing evidence, a risk analysis that does not reflect the current version of the device, a clinical evaluation that does not cover every claimed indication.
This kind of inconsistency is invisible from the inside. The people who built the file know what they meant to say.
Class I: nobody will review your file
For a class I device that is non-sterile, has no measuring function and is not reusable, there is no Notified Body. You draw up your declaration of conformity and place the device on the market.
That is freedom, and it is also a trap. No third party will ever review your technical file before it is needed, and it will be needed at exactly the moment you want it to be flawless: a competent authority inspection, a complaint, a vigilance incident, or a request from a key account customer.
For these devices, an independent review before placing on the market is the only critical reading they will ever get.
Consistency is a volume problem
Checking that a technical file is complete is tedious but feasible by hand. Checking that it is consistent is a different matter: you have to keep the claims, the GSPR checklist, the risk analysis, the clinical evaluation report, the labelling and the instructions for use in mind all at once, then spot where they contradict each other.
That is exactly what the platform does well. It reads the whole file, cross-checks the references and surfaces contradictions, including between documents that nobody ever reads side by side.
Our experts start from these findings to make the judgement that matters: will this gap trigger a question from the Notified Body, and if so, how do you answer it before it is asked?
Two ways to audit your technical file
This page describes a service: our experts carry out the review and deliver their conclusions to you.
If you would rather your own teams ran the analysis themselves, continuously and across your whole portfolio, what you need is the platform's Technical File module. You stay in control, the tool does the analysis.
The two are often combined: a review by our experts before the first submission, then a subscription to keep the file up to date afterwards.
See the Technical File moduleFrequently asked questions
When the file is complete in your eyes, and before it is sent. Too early, and the review covers a moving document. Too late, and there is no time left to correct it. In practice, plan the review a few weeks before your target submission date.
All of them, from class I to class III and implantable devices. The stakes of an independent review rise with the class, but class I deserves particular attention: without a Notified Body, nobody else will review the file.
You get a prioritised list that separates what will trigger a request for additional information from what could simply be improved. If the number of gaps puts your submission timeline at risk, we tell you clearly, because that is more useful than a reassuring report.
The review covers the consistency between the clinical evaluation and the rest of the file: claimed indications, risk analysis, labelling. Writing or overhauling a clinical evaluation report is a separate matter, which we scope separately.
That is a different service: non-conformity analysis and response, which starts from the report you received to build the root cause analysis, the CAPA plan and the responses. Tell us about your situation and we will point you to the right service.
Submission coming up?
Tell us about your device, its class and your deadline. Scoping is free, and we will tell you honestly whether there is still time for a useful review.