Custom-made devices
Custom-made devices are defined and regulated under Regulation 3 and Part I, Schedule 3, Annex VIII equivalent of the UK MDR 2002. The custom-made exemption provides a modified conformity assessment pathway — not a full exemption from regulatory requirements.
Definition of a custom-made device
A custom-made device is defined in UK MDR 2002 as a device:
Manufactured specifically in accordance with a written prescription of a duly qualified medical practitioner (or another person authorised by virtue of their professional qualifications) which gives, under the responsibility of such a practitioner, specific design characteristics, and intended for the sole use of a particular named patient.
Three conditions must all be met:
| Condition | Requirement |
|---|---|
| Written prescription | Actual written instruction from the practitioner — not a general specification |
| Specific design characteristics | The prescription specifies the design, not just a catalogue selection |
| Named patient | Made for a specific individual patient, not a range of sizes or configurations |
Mass-produced devices — even if later adjusted for a patient — are not custom-made devices.
What does NOT qualify as custom-made
| Situation | Custom-made? | Reason |
|---|---|---|
| Standard implant selected from a range for a patient | ❌ No | Catalogue selection, not design prescription |
| 3D-printed implant based on a patient's CT scan | ✅ Potentially | If designed to prescription for a named patient |
| Patient-matched implant templated from population data | ❌ No | Not truly custom to the individual patient's anatomy |
| Trial denture for fitting (later replaced by a definitive appliance) | ❌ No | For fitting purposes, not the final device |
| Hearing aid programmed for a patient's audiogram | ❌ No | Standard product with programming — not a custom design |
| Spectacle lenses ground to a patient's prescription | ✅ Yes | Ground to specific diopter prescription for named patient |
Modified conformity assessment for custom-made devices
Custom-made devices are exempt from the standard conformity assessment procedures (Annex II–VII equivalents) but must comply with an Annex VIII equivalent statement.
The manufacturer must produce a statement covering:
- Manufacturer identification — name and address
- Patient identification — the data necessary to identify the particular patient
- Name of the prescribing practitioner — or other authorised person
- Specific features of the device as indicated in the written prescription
- Statement that the device conforms with the Essential Requirements of UK MDR 2002 (Schedule 1 / Schedule 1A) and, where applicable, an indication of Essential Requirements not fully met, with reasons
- Declaration that the device is intended for the named patient alone
This statement replaces the UK Declaration of Conformity for custom-made devices but does not replace the underlying obligation to meet the Essential Requirements.
Essential Requirements still apply
Custom-made devices must meet all applicable Essential Requirements — they are not exempt from safety and performance obligations. The difference is that the conformity assessment route is simplified (no UKAB required for most custom-made devices), not that the requirements themselves are relaxed.
Manufacturers of custom-made devices must:
- Maintain a QMS appropriate to their activities (ISO 13485 expected)
- Document the design and manufacture process
- Assess and manage risks (ISO 14971)
- Provide appropriate instructions for use
- Maintain records of each custom-made device and the patient for whom it was made
Record-keeping requirements
Records for custom-made devices must be retained for:
- Minimum 5 years from the date of manufacture
- Minimum 15 years for implantable custom-made devices
Records must include:
- The written prescription
- The patient identifier
- The design specifications
- The manufacturing records
- The statement of conformity
MHRA registration for custom-made devices
Manufacturers of custom-made devices must register with MHRA as a manufacturer. Individual custom-made devices are not individually registered in the MHRA Submissions portal (unlike standard devices), but the manufacturer's registration as a custom-made device manufacturer is required.
Examples of custom-made devices
| Device type | Notes |
|---|---|
| Custom orthopaedic implants (e.g., patient-specific knee implant from CT data) | If designed to individual patient anatomy per written prescription |
| Custom spinal implants | For complex spinal deformity cases where standard implants are inadequate |
| Custom dental prostheses (crowns, bridges, dentures) | Made to a dentist's written prescription for a named patient |
| Patient-specific craniofacial implants | Designed from CT/MRI to fit a specific patient's defect |
| Bespoke orthotics and prosthetics | Made to a written clinical prescription for a named patient |
| Custom-made spectacle lenses | Ground to a named patient's optical prescription |
Related pages
- Who needs to comply?
- Classification — Class I · IIa · IIb · III
- Essential Requirements overview
- MHRA registration
Official references
| Reference | Description |
|---|---|
| UK MDR 2002, Regulation 3 | Custom-made device definition |
| UK MDR 2002, Schedule 3, Annex VIII equivalent | Custom-made device statement requirements |
| MHRA: Custom-made medical devices guidance | MHRA guidance on custom-made devices |
| ISO 13485:2016 | QMS — applicable to custom-made device manufacturers |