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Custom-Made Devices

Definition​

A custom-made device is a device that is:

  • Manufactured to meet the specific needs of a named patient
  • Made on the written instructions of a healthcare professional
  • Not manufactured in series — it is not a standard product adapted for the patient

Examples​

  • Orthopaedic implants made to fit a specific patient's anatomy (based on imaging data)
  • Dental prosthetics (crowns, bridges, dentures) made from patient impressions
  • Hearing aids made to fit the specific shape of a patient's ear canal
  • Custom orthotics or prosthetics

Regulatory status​

Custom-made devices are exempt from the Device Licence requirement under the MDR. They do not need to be listed in MDALL.

However, custom-made devices are not exempt from all obligations:

  • Must still meet the Safety and Effectiveness Requirements of Schedule 1
  • Must carry compliant labelling identifying the device and the prescribing healthcare professional
  • Manufacturers must maintain records of each custom device made
  • Adverse event reporting obligations still apply

Distinction from "made-to-order" devices​

Mass-produced devices that are simply selected from a standard catalogue to suit a patient's needs (e.g., selecting an implant of the correct size from a standard range) are not custom-made devices — they are standard devices and require a Device Licence.

True custom-made devices are one-of-a-kind products made from scratch for a specific patient.

Documentation​

For a device to qualify as custom-made, the manufacturer must retain:

  • The written prescription/instruction from the healthcare professional
  • The patient's name or unique identifier
  • A description of the specific design characteristics
  • Records of materials used and manufacturing steps

Legislative source: Medical Devices Regulations, SOR/98-282, s 63 (exemptions)