Custom-made devices
Custom-made devices are defined and regulated under Schedule 2, Rule 7 and Regulation 3 of the UK MDR 2002, with conformity assessment per Annex VIII equivalent (Schedule 3, Part I). 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 |
Manufacturers of custom-made devices are required to register with MHRA as manufacturers on the UK medical device register. Registration is mandatory regardless of whether the device is for the UK market or export-only. A separate device registration is not required for each custom-made device; manufacturer-level registration covering custom-made device activities is sufficient. Manufacturers must provide details of their quality management system, manufacturing premises, and contact information to MHRA.