Schedule 2 — Classification Rules
What Schedule 2 does
Schedule 2 of the Medical Devices Regulations contains the 16 classification rules used to assign medical devices to one of four classes (Class I–IV). It also contains separate classification rules for IVD devices.
Non-IVD classification rules (Rules 1–16)
The 16 rules cover different device categories based on their characteristics. A brief summary:
| Rules | Device category |
|---|---|
| Rule 1 | Devices that do not touch the patient or touch only intact skin |
| Rule 2 | Devices in contact with mucous membranes |
| Rule 3 | Surgically invasive devices (transient use) |
| Rule 4 | Surgically invasive devices (short-term use) |
| Rule 5 | Surgically invasive devices (long-term use / implantable) |
| Rule 6 | Devices implanted in teeth |
| Rule 7 | Active therapeutic devices |
| Rule 8 | Active devices for diagnosis and monitoring |
| Rule 9 | Devices that emit ionising radiation |
| Rule 10 | Devices in contact with the central nervous system |
| Rule 11 | Devices in contact with the cardiovascular system |
| Rule 12 | Reusable surgical instruments |
| Rule 13 | Devices used with another device |
| Rule 14 | Active devices (not covered by rules 7–9) |
| Rule 15 | Blood bags |
| Rule 16 | All other devices not classified by rules 1–15 (default Class I) |
IVD classification rules
Separate rules apply to IVD devices. They classify IVDs based on:
- The seriousness of the condition the IVD tests for
- The impact of an incorrect result on patient and public health
- The intended user (laboratory professional vs. lay user)
The highest-class-wins principle
When more than one rule applies to a device, the device is classified at the highest applicable class. This is the most important practical principle in applying Schedule 2.
Official source