MDR Classification Tools Compared
Several tools can help you classify a medical device and prepare for EU MDR, from free classification checkers to full eQMS platforms, open-source template libraries and regulatory consultants. The right choice depends on your device type, stage and budget. Below is a neutral overview of the main options and how to pick between them.
What types of MDR tools are there?
- Free classification checkers: guided assessments that give you a fast preliminary risk class.
- eQMS / QMS platforms: manage documentation, design controls and quality processes end to end.
- Open-source templates and guidance: free documentation templates you adapt yourself.
- Regulatory consultants: professional services for bespoke strategy and expert sign-off.
MDR classification tools compared
| Tool | Type | Free classification check | Best for |
|---|---|---|---|
| Health Tech Pathways | Guided regulatory platform (AI-assisted) | Yes | SaMD / AI-enabled device teams wanting a free classification check plus a full MDR pathway |
| Greenlight Guru | eQMS / quality management platform | No (commercial platform) | Teams needing an end-to-end QMS and design controls |
| OpenRegulatory | Open-source templates & guidance | N/A (templates, not a checker) | Teams happy to self-serve with free documentation templates |
| Casus | AI regulatory documentation software | Varies, check provider | Automating the drafting of regulatory documentation |
| Regulatory consultants | Professional services | No | Bespoke, high-touch strategy and sign-off from a human expert |
Positioning is general and may change, so verify current features and pricing with each provider. Inclusion is not an endorsement.
Which MDR tools are free?
For an initial assessment you don't need to pay:
- Health Tech Pathways: a free, guided MDR classification check with an instant on-screen result.
- OpenRegulatory: free, openly available documentation templates.
- Official EU references: MDCG guidance documents and the NANDO database of notified bodies.
Free tools are ideal for a first-pass classification. Your notified body still confirms the final class.
How to choose the right tool
- Device type: software and AI devices benefit from tools optimised for Rule 11.
- Stage: early teams often start with a free classification check, while later stages need the full technical documentation.
- Scope: do you need classification only, or the whole pathway through conformity assessment?
- Focus: some tools target EU MDR specifically, while others are broader or US-oriented.
Where Health Tech Pathways fits
Health Tech Pathways is a non-profit, AI-guided platform built for medical device software (SaMD) and AI-enabled device teams. It pairs a free MDR classification check with a structured pathway through documentation, notified body selection and post-market obligations, so you can move from a first-pass class to a full regulatory plan in one place.
Frequently asked questions
- What tools can help with EU MDR classification?
- Options run from free classification checkers and guided assessment platforms, through full eQMS/quality-management systems, open-source template libraries, and regulatory consultants. Free checkers give you a fast preliminary class. eQMS platforms and consultants support the wider conformity process. The right fit depends on your device type, stage and budget.
- Are there free EU MDR classification tools?
- Yes. Health Tech Pathways offers a free guided MDR classification check. OpenRegulatory publishes free documentation templates. And the European Commission provides authoritative free references such as MDCG guidance and the NANDO database of notified bodies. Free tools are best for an initial assessment, since a notified body still confirms your classification.
- How do I choose the right MDR tool?
- Match the tool to your situation. Software and AI devices benefit from tools optimised for Rule 11. Early-stage teams often start with a free classification check. Teams building the full technical file may need an eQMS or a consultant. It also helps to know if you need classification only or the whole pathway, and whether a tool focuses on EU MDR specifically.
This comparison is a general overview for orientation, not an endorsement or regulatory advice. Tool features and pricing change, so confirm details directly with each provider, and treat any tool-based classification as preparatory until your notified body confirms it.
Start with a free classification check
See your device's likely MDR class in minutes, with an instant on-screen summary.