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A distributor receives the EU declaration of conformity, a certificate and a list of standards from its manufacturer, and the question it puts to us is nearly always the same: is this right? To answer it quickly and at a limited cost, we are launching the EU conformity diagnostic for medical devices and in vitro diagnostic medical devices: a documentary review of limited scope that places the product against the regulation that applies to it, the harmonised standards in force and any other legislation that may also reach it.
What the EU conformity diagnostic for medical devices is
It is a light, limited-scope documentary review. It is designed for manufacturers, importers, distributors and brand owners who are about to place a medical device or an IVD on the European Union market, or who want to confirm that the product they already sell complies. It is not an audit of the technical documentation and does not replace one: it is the step before, the one that tells you whether that documentation holds up and, if it does not, where to start.
The reference is Regulation (EU) 2017/745 on medical devices (MDR) or Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), depending on the product, together with the standards and horizontal legislation that belong to its type. A sterile dressing is not reviewed the same way as an electromedical device, a piece of software or a self-test, and the diagnostic adapts to each case.
What we review
We start from the documentation you already have. We check the EU declaration of conformity and the CE marking: who signs it, which product and class it declares and under which conformity assessment procedure. We review the labelling and the instructions for use against the requirements of the regulation, as well as the notified body and quality management system (ISO 13485) certificates, with their scope and validity.
We then compare the standards and tests declared by the manufacturer with the harmonised standards published in the Official Journal of the EU and, where a standard is not harmonised, with the state of the art. Finally, we identify the legislation that may apply in addition to the MDR or the IVDR depending on the product: hazardous substances in electrical equipment (RoHS), waste electrical and electronic equipment (WEEE), batteries, REACH, packaging, radio equipment and, if the product can reach consumers, the General Product Safety Regulation. If you import devices, our guide to importer obligations under the MDR explains what you must check before a device is placed on the market.
Why harmonised standards deserve a review of their own
In our experience, this is where a file goes out of date without anyone noticing. The question is not whether the product has a list of standards, but whether what that list declares still holds today. The Commission has amended the lists of harmonised standards for the MDR and the IVDR several times since 2025, most recently in June 2026. One concrete example: EN ISO 10993-1:2025, on biological evaluation, has been listed as harmonised since June 2026 under Commission Implementing Decision (EU) 2026/1231. A technical file that still declares the 2020 edition does not benefit from that presumption of conformity; it will need to be updated or the difference justified.
That is why the diagnostic does not stop at checking that a list of standards exists: it verifies each declared edition against the lists in force on the date of the review, both the harmonised standards for medical devices and those for in vitro diagnostic medical devices. Outdated or incomplete standards are also among the reasons a file comes back from the notified body, as we explain in why notified bodies reject MDR technical documentation.
The GPSR, only if the product can reach consumers
Regulation (EU) 2023/988 on general product safety (GPSR) often comes up in medical device queries, usually with a broader scope than it actually has. It only comes into play if the product is intended for consumers or is likely to be used by them and, even then, its Article 2 limits it to the risks that the MDR and the IVDR do not cover and excludes several of its chapters while keeping others; among them, it may affect the information required for distance sales (Article 19) and the obligations of online marketplaces (Article 22); how other provisions, such as those on product recalls, fit with MDR and IVDR vigilance has to be assessed case by case. The diagnostic looks at it only when it applies, without loading you with obligations that are not yours. For the importer’s side, see our article on GPSR for importers.
What you receive and what is not included
The result is a short report with a traffic-light rating by area, the gaps in order of priority and, for each one, the way to resolve it: we do not deliver a list of requirements without the route to meet them. It also includes the proposed risk class and the framework that applies to the product; the class is a proposal that must be confirmed with the complete documentation.
Drafting or auditing the technical documentation, and drafting any document, are not included and are quoted separately. If the diagnostic shows that this work is needed, the report already sets out its scope, so the next step is assessed on facts rather than assumptions. If the doubt is about the declaration itself, our complete guide to the CE declaration of conformity is a good place to start.
Frequently asked questions
Does it replace the notified body’s assessment?
No. The diagnostic reviews the documentation you provide and tells you where it stands; the conformity assessment, where the regulation requires a notified body, remains the notified body’s.
What about class I devices?
For MDR class I devices that are not sterile, have no measuring function and are not reusable surgical instruments, the manufacturer declares conformity itself, without the involvement of a notified body (Article 52(7) of the MDR). No one outside checks that declaration, and the diagnostic is the quickest way to do so.
Does it work for a product already on the market?
Yes. It is just as useful before placing a product on the market as it is to confirm that one already being sold still complies, for example after a change in the harmonised standards.
How to request it
We need the EU declaration of conformity, the label and instructions for use, the certificates available, the manufacturer’s list of standards and tests and, if the product is sold online, the link to its product page. With that documentation we prepare the quotation, and the review starts once it has been accepted and paid. The full scope of the EU conformity diagnostic for medical devices is set out in the service leaflet (PDF).
If you are about to place a medical device or an IVD on the EU market and have not yet checked its documentation against the harmonised standards in force, tell us about your product and we will tell you what to gather.
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