You can work out much of the pathway yourself
The rules for qualification, classification and conformity assessment are public. For many products, a manufacturer can establish a good first regulatory position without engaging a consultant.
The starting point is not a classification database or a precedent from another product. It is the intended purpose of your own product.
1. First ask: is it a medical device or IVD?
Start with the definitions in the MDR and IVDR.
For software, the most useful practical guidance is MDCG 2019-11 Rev.1: Qualification and Classification of Software. It explains when software qualifies as medical device software and how MDR and IVDR classification principles apply.
If the answer is unclear, look at the European Commission's Manual on Borderline and Classification. It contains worked examples of products where the regulatory status or classification has required interpretation.
A useful first question is:
What exactly does the product do, for whom, and for what medical purpose?
Marketing language, instructions for use, product functionality and intended purpose need to tell the same story.
2. For a medical device, apply the MDR classification rules
The MDR classification rules are in Annex VIII of Regulation (EU) 2017/745.
The Commission's MDCG 2021-24 Rev.1: Guidance on Classification of Medical Devices explains how those rules should be applied and gives examples.
For software, pay particular attention to Rule 11. Classification depends on what the information generated by the software is used for and the potential consequences of the decisions it supports. Medical device software is therefore not automatically Class IIa.
Work through the rules against the actual intended purpose and document why the applicable rule does, and the alternatives do not, apply.
3. For an IVD, use the IVDR rules
IVDs are classified as A, B, C or D under Annex VIII of the IVDR.
The main practical resource is MDCG 2020-16 Rev.5: Guidance on Classification Rules for IVDs, updated in September 2026.
The guidance includes examples and explains how the intended purpose, population, analyte and consequences of an incorrect result affect classification.
For IVDs in particular, small differences in intended purpose can produce different classifications. Screening, diagnosis, companion diagnostics, infectious disease testing and genetic testing, for example, need to be considered against the specific IVDR rules rather than grouped together simply because they use similar technology.
4. Then determine the conformity assessment route
Once the classification is established, look at:
- MDR Article 52 and Annexes IX–XI for medical devices
- IVDR Article 48 and Annexes IX–XI for IVDs
These provisions set out the available conformity assessment procedures and when a Notified Body is required.
Classification matters because it changes the level of external conformity assessment. But it is worth following the actual route through the Regulation rather than using a shortcut such as “Class II means I need a Notified Body.”
5. Check which Notified Bodies can actually assess the product
If Notified Body involvement is required, use the European Commission's NANDO database.
A Notified Body being designated under the MDR or IVDR does not mean it can assess every type of device. Its designation has a defined scope.
You can therefore check:
- whether the organisation is designated under MDR or IVDR
- its conformity assessment activities
- the device or technology codes within its designation
EUDAMED can also be used to review publicly available information on certificates issued by Notified Bodies.
A sensible DIY regulatory pathway
Before paying anyone for classification advice, you should be able to write down:
Product → intended purpose → MDR / IVDR qualification → applicable classification rule → class → conformity assessment route → Notified Body involvement
And, for each step:
What is the regulatory source for this conclusion?
If you can do that clearly and there is little room for alternative interpretation, you may not need a classification consultancy project at all.
Where Fabola comes in
The difficult cases are not difficult because the regulations are unavailable.
They are difficult because several defensible interpretations may be possible, and the choice can have significant consequences later.
This is particularly common with:
- AI and medical device software
- medical versus wellness positioning
- software that could fall under either MDR or IVDR
- multiple functions or intended purposes
- diagnostic, screening or prediction claims
- products where apparently small changes in wording change the classification
- novel technologies without an obvious regulatory precedent
Fabola works through the same public rules and guidance, but adds regulatory interpretation, experience and challenge.
A central part of this work is often the intended purpose. We help you turn what the product actually does, who it is for, where it is used and what decisions it supports into a precise regulatory intended purpose.
That wording matters. It becomes a reference point for classification, clinical or performance evidence, risk management, technical documentation and conformity assessment. It also gives you a clearer and more consistent basis for discussions with Notified Bodies, competent authorities and other regulators.
We therefore do not simply tell you which class we think the product belongs in. We help establish the regulatory logic behind it:
product → intended purpose → claims → qualification → classification → conformity assessment pathway
The aim is not to find the lowest possible classification or to word the intended purpose around the rules. It is to define the product accurately and establish a pathway that is defensible, proportionate and consistent with the product you actually intend to put on the market.