Device-level registration requirements
Regulatory basis
Device-level registration requirements are established by the UK MDR 2002 as amended and MHRA registration guidance. Each distinct device or device family placed on the GB market must be registered.
What constitutes a "device" for registration purposes?
MHRA registers devices at the level of device families or groups — not necessarily every individual model or configuration. A device family typically includes devices with the same:
- Intended purpose
- Design principles
- Classification
- Conformity assessment basis
Manufacturers should consult MHRA's current registration guidance for the specific grouping rules, as these have evolved.
Information required at device level
For each registered device or device family, MHRA requires:
| Field | Description |
|---|---|
| Device name | Trade name and/or generic name |
| Device description | Brief description of the device and its intended purpose |
| Classification | Class I / IIa / IIb / III / AIMD / IVD category |
| UKCA or CE basis | Which conformity mark is being relied upon for GB market access |
| Certificate reference | UKAB certificate number + UKAB name (UKCA route); or EU Notified Body certificate + framework (CE transitional route) |
| DoC reference | Reference to the UK Declaration of Conformity |
| Sterile / measuring / reusable | Sub-category designation for Class I devices |
Updating device registrations
Device registrations must be updated when:
- A new model is added to an existing registered family
- Classification changes
- A new certificate is issued (renewal or change of UKAB)
- A CE certificate expires or is superseded
- A device is withdrawn from the GB market
Official references
| Reference | Description |
|---|---|
| UK MDR 2002 | Device registration obligations |
| MHRA: Registering medical devices | Device registration guidance |