Free EU MDR Medical Device Classification Tool
This free medical device classification tool helps manufacturers, regulatory affairs professionals and consultants determine the correct classification for a medical device under EU MDR 2017/745 Annex VIII. Simply work through the step-by-step questions and the tool will identify whether your device is Class I, Class IIa, Class IIb or Class III under the EU Medical Device Regulation.
No sign-up or registration required — this MDR classification tool is completely free to use.
How to Use This MDR Classification Tool
Work through the questions in sequence based on your device’s intended purpose, invasiveness, duration of use and whether it is active or non-invasive. Where more than one classification rule applies, the tool will guide you to the highest applicable classification. Key definitions are provided throughout to assist with each decision.
About EU MDR Device Classification
Under EU MDR 2017/745, all medical devices placed on the European market must be assigned a risk-based device classification in accordance with Annex VIII of the regulation. Classification determines the level of conformity assessment required before a device can be CE marked:
- Class I — lowest risk, self-certified by the manufacturer
- Class IIa — low to moderate risk, requires notified body involvement
- Class IIb — moderate to high risk, requires notified body certification
- Class III — highest risk, requires full notified body design examination
Correct device classification is a critical first step in your CE marking pathway. If you need support interpreting your classification result or planning your regulatory strategy, Practical RA offers EU MDR regulatory consulting services.
Frequently Asked Questions
What is EU MDR 2017/745 device classification? EU MDR 2017/745 requires all medical devices to be classified into one of four risk classes (Class I, IIa, IIb or III) based on the rules set out in Annex VIII of the regulation. Classification is based on the device’s intended purpose, invasiveness, duration of use and whether it is active or non-invasive.
Is this MDR classification tool free? Yes — this tool is completely free to use with no sign-up or registration required.
Does this tool cover IVD devices? No. This tool covers medical devices under EU MDR 2017/745 only. In vitro diagnostic devices are classified separately under EU IVDR 2017/746.
What if more than one classification rule applies to my device? Where multiple rules apply, the correct classification is always the highest. The tool guides you through this where relevant.
Can I use this tool for TGA device classification in Australia? The TGA uses a similar risk-based classification framework for medical devices, however the rules differ from EU MDR. Contact Practical RA if you need guidance on TGA device classification for the Australian market.
What should I do after I determine my device classification? Your classification determines your CE marking pathway and the level of technical documentation required. If you need help planning your regulatory strategy or preparing technical documentation, get in touch with Practical RA.