Regulatory strategy: classification decides everything else.
Product qualification, classification, applicable requirements and standards, route to market, action plan and timeline. For a new product, a new market or a new country.
Initial scoping is free, with no commitment. Fixed-price service.
What you get
- Qualification and classification
- Applicable requirements and standards
- Market access route
- Action plan and timeline
Good to know
- Typical cases: new product, new market, new country
Ideal if: you are launching a new product, targeting a new market or a new country, and the regulatory route is not mapped yet.
Two questions that come before all others
Everything hinges on two decisions, and they are harder than they look.
Is your product a medical device?
Qualification depends on the intended purpose you give it, not on its technology. The same software can be a medical device or not, depending on what you claim for it. Your claims are what commit you, including those on your website and in your sales materials.
Which class does it fall into?
The classification rules in MDR Annex VIII depend on duration of contact, invasiveness, whether the device is active and the part of the body concerned. A change of class determines whether a Notified Body is involved, and changes the content of the technical file, the clinical requirements, the cost and the timeline.
The cost of an optimistic classification
The most common mistake is not getting it wrong through ignorance. It is choosing, out of two defensible readings, the one that suits the timeline.
The price is paid later, and it is out of all proportion. A file built for class IIa that a Notified Body reclassifies as IIb means a clinical evaluation to redo, additional requirements to document, and several months lost just when the team thought it was done.
A classification that is properly established and argued from the outset costs less than any later correction, even when it leads to a higher class than you hoped for.
Three typical situations
New product
You are designing a device and the route has not been mapped out. We establish qualification, classification, applicable requirements and the standards to meet, then the timeline for placing on the market, with its dependencies.
New market
An existing product is aimed at a different use, population or indication. Requalification is often necessary, and the question is what can be reused from the existing file.
New country
CE marking does not open up the whole world. Each jurisdiction has its own requirements, its own local representative and its own registration timeline. The strategy is to sequence these markets rather than tackle them all at once.
Frequently asked questions
It depends on its intended purpose, not its technology. Software that supports a diagnostic or therapeutic decision generally falls under the MDR, whereas an administrative management or wellness tool does not. The sensitive point is that your own marketing claims play a part in qualification: what you state on your website commits you.
It can be discussed, provided you bring solid arguments based on the Annex VIII rules and the applicable MDCG guidance. That is why the classification rationale must be written and documented from the outset, not pieced together after the fact under pressure.
Ideally yes, because classification determines design requirements that are costly to add later. In practice, many teams come to us once a prototype exists. It is still useful, but some decisions are then more constrained.
No. Each jurisdiction applies its own framework, with its own registration requirements, local representative and lead times. CE marking makes some steps easier without exempting you from them. The strategy is precisely about sequencing these markets according to your real capacity.
The argued qualification and classification, the list of applicable requirements and standards, the chosen route to market, then an action plan with a timeline and the dependencies between steps. It is designed to be presented to an investor or a management committee.
A product whose route has not been mapped out?
Tell us about the device, its claimed intended purpose and your target markets. Scoping is free.