This purpose of this blog is to explain Medical Device Classification in the EU as well as what Medical Devices belong in which relevant class.
The European Union (EU) device classification system has some differences from the United Kingdom (UK) and FDA’s classification, as well as some similarities to both, so it’s well worth taking note.
If you need help with device classification to market your device in the EU, the patient guard team can provide this in our services. But first, let’s explain what is required to meet the EU classifications for medical devices.
The Purpose of Medical Device classification
The classification of medical devices in the EU is based on the potential risks that the devices can impose to the human body from contact with or use of the devices. The EU classification rules are set out in Annex VIII of Medical Device Regulation (EU) 2017/745 (MDR).
How many device classes exist in EU MDR 2017/745?
The EU MDR 2017/745 currently has 4 main medical device classification categories and three sub-categories:
Class I Medical Devices
A Class I medical device in the EU present the lowest risk, medical manufacturers can usually self-certify class I devices without requiring a notified body.
Examples of Class I Medical Devices
Sub-classifications for Class I Medical Devices
Additionally, under class I, there are subclasses that are higher risk that require a notified body;
Class IIa Medical Devices
Examples of for Class IIa Medical Devices
Class IIb Medical Devices
Examples of for Class IIb Medical Devices
Class III Medical Devices
The final device classification in the EU is class III devices. These are devices that pose the highest risk to patient safety, as with the UK and FDA’s versions of Medical Device classifications. Class III devices require a notified body and a complete clinical evaluation on the device.
Examples of class III Medical Devices
Conclusion

Connor is a recent graduate in ‘Digital Media and Web Technologies”, where he graduated with a First Class Honours degree at Blackpool & The Fylde College. Connor joined Patient Guard in September 2021 as the digital marketing assistant.