Custom-Made Medical Devices in France under EU MDR

Definition of Custom-Made Devices

According to Article 2(3) of Regulation (EU) 2017/745 (MDR), a custom-made device is any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications which gives, under the person’s responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. Mass-produced devices adapted to meet the specific needs of any particular patient are not considered custom-made. Dispositifs médicaux sur mesure - ANSM

Scope and Exclusions

• Custom-made devices cover a wide range of products, such as dental prostheses, orthopaedic appliances, ocular prostheses, and certain hearing aids made to individual specifications.
• Devices produced in series and then adapted (e.g., standard orthoses adjusted on-site) are not custom-made and must follow standard conformity assessment.
• The MDR applies fully to custom-made devices placed on the market in France, with specific derogations from certain conformity assessment procedures.

Obligations of the Manufacturer

Manufacturers of custom-made devices must:

• Ensure the device meets the general safety and performance requirements set out in Annex I of the MDR.
• Draw up a written declaration in accordance with Annex IV of the MDR.
• Maintain technical documentation as specified in Annex II and Annex III (adapted for custom-made nature).
• Implement a quality management system (QMS) proportionate to the risk class and type of devices.
• Register in EUDAMED and assign a Unique Device Identifier (UDI) where applicable (for certain classes).
• Undertake post-market surveillance and vigilance obligations.

Statement and Documentation Requirements

The manufacturer must draw up a statement containing:

• Name and address of the manufacturer.
• Data allowing identification of the device.
• Statement that the device is intended for the sole use of a particular patient.
• Name of the prescribing healthcare professional.
• Specific characteristics of the device.
• Declaration of conformity with MDR general safety and performance requirements.

This statement must be kept available for competent authorities (e.g., ANSM) for at least 5 years (or 15 years for implantable devices).

Registration and Traceability

• Manufacturers of custom-made devices must register in the EUDAMED actor module and obtain a Single Registration Number (SRN).
• For devices in higher risk classes, additional requirements may apply.
• The prescription and statement must enable traceability to the specific patient.

Conformity Assessment Derogations

Custom-made devices are exempt from the full conformity assessment procedures involving notified bodies (Annexes IX, X, XI), provided the manufacturer complies with the specific obligations above. However, they remain subject to market surveillance by competent authorities.

Practical Considerations in France

• ANSM may request documentation or conduct inspections of custom-made device manufacturers.
• Healthcare professionals prescribing custom-made devices should ensure the prescription contains sufficient detail for safe manufacture.
• Manufacturers are encouraged to consult ANSM for borderline cases or complex custom devices.
• The framework balances flexibility for individual patient needs with appropriate safety and performance safeguards.

This regime ensures that patients in France can access truly individualized medical solutions while maintaining high regulatory standards. Dispositifs médicaux sur mesure - ANSM