Custom-made devices
MDR Art. 2(3) (definition); MDR Art. 52(8) (conformity assessment); MDR Annex XIII (documentation requirements for custom-made devices). Custom-made devices are subject to a specific, lighter-touch regulatory pathway but must still meet all applicable GSPR.
This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.
Definition of a custom-made device
A custom-made device is a device specifically made in accordance with a written prescription of any person authorised by national law — typically a qualified medical practitioner — which gives, under that person's responsibility, specific design characteristics and is intended for the sole use of a particular patient.
Mass-produced devices that need to be adapted to meet the specific requirements of a medical practitioner or any other professional user are not custom-made devices.
Key distinguishing features
| Custom-made device | NOT a custom-made device |
|---|---|
| Made for a specific, named patient | Made for a general category of patients |
| Based on a written prescription from an authorised person | Made to a healthcare professional's general specification without patient-specific prescription |
| One-off manufacture or very limited quantity | Mass-produced and then adapted |
| No CE mark is affixed | CE mark required |
Common examples
- Dental prosthetics, crowns, bridges, and orthopaedic appliances made to individual impressions
- Orthopaedic implants made to patient-specific anatomical measurements
- Hearing aid shells moulded to an individual patient's ear canal
- Patient-specific surgical cutting guides (3D printed)
- Bespoke compression garments made to individual measurements
- Customised orthotics and prosthetics
Conformity assessment — MDR Art. 52(8) and Annex XIII
Custom-made devices do not follow the standard conformity assessment procedures. Instead, the manufacturer must:
1. Prepare a statement (Annex XIII statement)
For each custom-made device (or type of custom-made device), the manufacturer must prepare a written statement containing:
| Element | Description |
|---|---|
| Manufacturer identification | Name, address |
| Data identifying the device | Name, type, description |
| Patient identification | Name or unique reference (anonymised) |
| Name of prescriber | The authorised professional who issued the prescription |
| Specific characteristics | Per the prescription |
| Declaration | That the device conforms to the GSPR |
| Manufacturing site | Where the device was made |
For Class III custom-made devices and Class IIb custom-made implantable devices: the statement must also include a clinical evaluation.
2. Keep documentation available
The Annex XIII documentation must be kept available for inspection by competent authorities. Retention period: 15 years (30 years for implantable custom-made devices).
3. Implement a QMS
Custom-made device manufacturers must implement a QMS appropriate to their scale of activity. For manufacturers of Class IIa, IIb, or III custom-made implantable devices, the QMS must be assessed by a notified body.
GSPR compliance
Custom-made devices must meet all applicable GSPR — there is no GSPR exemption for custom-made products. The GSPR must be met for the specific device as prescribed.
No CE marking
Custom-made devices do not bear the CE mark. They are exempt from CE marking requirements precisely because they are not "placed on the market" in the standard sense — they are made for a specific patient under a specific prescription.
Economic operators
For custom-made devices, the roles of manufacturer, importer, and distributor apply as for standard devices. However, the prescribing professional also has responsibilities — specifically, the prescription must be written, identify the patient and their specific requirements, and be retained.
EUDAMED registration
Custom-made device manufacturers must register as economic operators in EUDAMED (obtain an SRN) but do not register individual custom-made devices in the device database.
Related pages
Official references
| Reference | Description |
|---|---|
| MDR Art. 2(3) | Custom-made device definition |
| MDR Art. 52(8) | Conformity assessment for custom-made devices |
| MDR Annex XIII | Documentation requirements |
| MDR Art. 10 | Manufacturer obligations (apply to custom-made) |
| MDCG 2021-3 | Guidance on custom-made devices |