Regulatory questions, answered

Not automatically.

The answer depends on what the software is intended to do with the information, what output it produces and the medical purpose of that output.

Software using laboratory data can potentially fall under IVDR, MDR or outside medical-device regulation depending on its intended purpose and functionality.

Potentially.

The important question is not simply whether the product uses AI.

Qualification depends on what the software is intended to do and whether its output serves a medical purpose such as diagnosis, prediction, monitoring or treatment.

Sometimes a product can legitimately remain outside medical-device regulation.

But “wellness” is not simply a label.

The functionality, intended purpose, claims, user experience, instructions and marketing all need to support that position.

Not if the early version is itself a medical device or IVD. Making a device available on the EU market, whether paid or free and whether called a beta or not, generally requires it to meet the MDR or IVDR first.

What is possible depends on what the early version does and claims. A version without a medical purpose may fall outside the regulations, and clinical investigations and performance studies follow their own rules. Deciding what the first version does is a regulatory decision as well as a product decision.

That follows from the intended purpose and the classification rules in Annex VIII of the MDR or the IVDR. Medical device software is mainly classified under MDR Rule 11; IVDs fall into classes A to D.

The class decides whether a Notified Body is needed and which conformity assessment routes are open, so it is worth establishing before planning around it.

That depends on whether your product qualifies as a medical device or IVD and how it is classified.

For many regulated devices, independent conformity assessment is required before CE marking.

The important step is to establish the pathway before planning around assumptions.