What are medical devices?
In simplified terms a medical device is an item or a substance which is made to:
• diagnose a medical condition
• prevent illness
• promote healing
• prevent conception
• alleviate incapacity
• replace anatomy or physiological process
which is not a medicine, cosmetic, food or personal protective equipment. (For the complete definition, refer to the Directives).
Within the EEA the term ‘medical device' comprises five main types:
| Type of medical device | Description | EU Primary Legislation |
| Active | Not gravity or manually powered | Medical Devices Directive |
| Active implantable | As active, but implanted for more than 30 days | Active Implantable Medical Devices Directive |
| Implantable | Implanted for more than 30 days | Medical Devices Directive |
| Non-active | Everything else neither active nor implantable | Medical Devices Directive |
| In vitro diagnostic | Diagnostics outside the body | In vitro Diagnostic Medical Devices Directive |
Medical Devices are classified according to their risk. In the EU there are nine different classes:
| Name | EU Legislation |
| Class I | Medical Devices Directive |
| Class IIa | Medical Devices Directive |
| Class IIb | Medical Devices Directive |
| Class III | Medical Devices Directive |
| Active implantable | Active Implantable Medical Devices Directive |
| IVD Annex II List A | In Vitro Diagnostic Medical Devices Directive |
| IVD Annex II List B |
In Vitro Diagnostic Medical Devices Directive |
| IVD for self testing | In Vitro Diagnostic Medical Devices Directive |
| IVD for professional use | In Vitro Diagnostic Medical Devices Directive |
Need help with device classification? Either read the Directives, or request a copy of the Priory Analysts EU medical device classification chart and then read the Directive/s.
