Classification Rules Reference
How the Rules Work
The classification rules are set out in the Schedule to the Medical Device Regulations 2012. Each rule assigns a device to a class based on its intended purpose, invasiveness, duration of contact, and other characteristics.
Key principle: Where more than one rule could apply, the highest resulting class applies.
Duration of Contact Definitions
| Category | Duration |
|---|---|
| Transient | Less than 60 minutes |
| Short-term | 60 minutes to 30 days |
| Long-term | More than 30 days |
Non-Invasive Device Rules
| Rule | Description | Class |
|---|---|---|
| Rule 1 | Non-invasive devices, generally | A |
| Rule 2 | Non-invasive devices intended to channel/store blood, body fluids or tissues, liquids/gases for infusion | A or B depending on application |
| Rule 3 | Non-invasive devices used to modify biological or chemical composition of blood, other body fluids, cells, or tissues for infusion back into body | C or D |
| Rule 4 | Non-invasive devices that come into contact with injured skin | A, B, or C depending on use |
Invasive Device Rules
| Rule | Description | Class |
|---|---|---|
| Rule 5 | Invasive devices for body orifices (transient) | A or B |
| Rule 6 | Invasive devices for body orifices (short-term) | B |
| Rule 7 | Invasive devices for body orifices (long-term) | B or C |
| Rule 8 | Surgically invasive devices for transient use | B or C |
| Rule 9 | Surgically invasive devices for short-term use | B or C |
| Rule 10 | Surgically invasive devices for long-term use | B, C, or D |
| Rule 11 | Long-term implantable devices | C or D |
Active Device Rules
| Rule | Description | Class |
|---|---|---|
| Rule 12 | Active therapeutic devices (energy delivery) | A, B, or C |
| Rule 13 | Active devices for diagnosis | A, B, or C |
| Rule 14 | Active devices that administer drugs/IVDs via a delivery mechanism | A or C |
| Rule 15 | Active implantable devices | D |
Special Rules
| Rule | Description | Class |
|---|---|---|
| Rule 16 | Devices specifically intended for recording diagnostic images from ionising radiation | C |
| Rule 17 | Devices for disinfecting, cleaning, rinsing medical devices | A or B |
| Rule 18 | Devices for contraception or prevention of sexually transmitted diseases | B or C |
| Rule 19 | Devices specifically intended for disinfecting, cleaning, rinsing contact lenses | C |
| Rule 20 | Devices incorporating animal/human tissues or their derivatives | C or D |
Worked Examples
Example 1: Sterile Urinary Catheter
- Invasive through body orifice
- Short-term use (< 30 days)
- → Rule 6 applies → Class B
Example 2: Total Hip Replacement
- Surgically invasive
- Long-term implantable (>30 days)
- Not in contact with CNS or CVS
- → Rule 11 applies → Class C
Example 3: Implantable Cardiac Pacemaker
- Active implantable device
- → Rule 15 applies → Class D
Example 4: Non-Sterile Examination Gloves
- Non-invasive
- Contact with intact skin
- Not in contact with injured skin
- → Rule 1 applies → Class A
Classification Queries
If the rules lead to an ambiguous outcome, submit a classification query to MDA via the MyMDA portal before investing in dossier preparation. A formal MDA determination is binding.