Qualify and classify your software in minutes.
MD or non-MD qualification followed by class determination, based on your product description. A first regulatory status is obtained for free in minutes, followed by an in-depth structured rationale.
A regulatory qualification that takes weeks.
Product teams developing health software all face the same initial question: does MDR apply or not, and if so, under which class? That answer drives everything else: clinical evidence, involvement of a notified body, depth of the technical file, timeline and budget. Finding it today requires back-and-forth with experts and reading through multiple texts — several weeks of work at a moment when the roadmap needs clarity.
Under-classifying risks non-compliance, over-classifying wastes time: the goal is to get it right from the start.
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A regulatory status in minutes.
From a product description, the tool applies the rules of MDR 2017/745 and IVDR 2017/746 to qualify your software and determine the associated class. The assessment is reasoned and traceable, ready to be discussed with stakeholders or added to the regulatory file.
Product description input
You describe the medical function of the software, its target users, and the clinical context of use.
MD or non-MD qualification
The tool applies MDR 2017/745 and IVDR 2017/746 to determine whether your software qualifies as a medical device.
Class determination
Based on the classification rules, the associated class is calculated: I, IIa, IIb, III for MDs, and A, B, C, D for IVDs.
Structured rationale
Each conclusion is supported by the invoked rules and their application to your case, ready to be included in the regulatory file.
Reference document
The assessment report is delivered in an exportable format, ready to be filed in the regulatory dossier or shared with stakeholders.
Discover your software's regulatory status right now.
Start the assessmentYour data is never stored or used to train the model.
