The Medical Device Directive establishes in Annex IX the different classifications for devices.
- Class I-Devices low risk such as stethoscopes, bandages, etc. The devices are non-evasive. The manufacturer must complete a technical file.
- Class I sterile-Devices are low risk such as stethoscopes, bandages, etc. The devices are non-evasive. The manufacturer must complete a technical file and apply to a European Notified Body to get certified in the area of manufacturing dealing with sterility.
- Class I measuring-Devices are low risk such as stethoscopes, bandages, etc. The devices are non-evasive. The manufacturer must complete a technical file and apply to a European Notified Body to get certified in the area of manufacturing dealing with metrology.
- Class IIa-Devices low-medium risk devices such as a hearing-aid. Devices that are within the body between 60 minutes and 30 days fall within this class. This class also warrants technical files as well as having a European Notified Body perform a conformity test.
- Class IIb-Devices are medium-high risk. The devices in this class are in the body more than 30 days. Examples include ventilators and intensive care monitoring equipment. Compliance route is the same as Class IIa with an additional step of type examination of the device by the European Notified Body.
- Class III These are high-risk devices. Some examples are balloon catheters and prosthetic heart valves. The steps to approval are audit of the full quality assurance system and examination of the design by the European Notified Body examination and testing of the device.
18 Rules of Classification
- Rule 1– Devices that either do not touch the patient or contact intact skin only.
- Rule 2 – Channeling or storing for eventual administration.
- Rule 3 – Devices that modify biological or chemical composition of blood, body liquids or other liquids.
- Rule 4 – Devices in contact with injured skin.
- Rule 5 – Devices invasive in body orifices.
- Rule 6 – Surgically invasive devices for transient use except if there are reusable surgical instruments.
- Rule 7 – Surgically invasive devices for short term use.
- Rule 8 – Surgically invasive devices for long term use and implantable devices.
- Rule 9 – Active therapeutic devices intended to exchange or administer energy.
- Rule 10 –Active devices for diagnosis.
- Rule 11 – Active devices to administer, remove medicines and other substances to or from the body.
- Rule 12 – All other active devices.
- Rule 13 – Devices incorporating a medicinal substance.
- Rule 14 – Devices used for contraception or prevention of sexually transmitted diseases.
- Rule 15 – Specific disinfecting, cleaning and rinsing devices.
- Rule 16 – Non-active devices to record X-ray diagnostic images.
- Rule 17 – Devices utilizing animal tissues or derivatives.
- Rule 18 – Blood bags.
For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.