Custom-Made Medical Devices in Norway

1. Definition

A custom-made device is a device that is specifically made in accordance with a written prescription of an authorised person with specific professional qualifications, and is intended for the sole use of a particular patient. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/devices-for-special-purposes/custom-made-devices

2. Examples

Examples of custom-made devices include dental devices such as crowns and bridges, and orthopaedic devices such as prostheses and special shoes. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/devices-for-special-purposes/custom-made-devices

3. General Requirements

The devices shall meet the general safety and performance requirements stated in MDR Annex I. Manufacturers shall follow the conformity assessment procedure stated in Annex XIII. Custom-made implants in class III shall be assessed by a notified body. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/devices-for-special-purposes/custom-made-devices

4. Statement of Conformity

A declaration must be prepared before the device can be sold. This declaration must include a statement that the device is intended only for one specific patient. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/devices-for-special-purposes/custom-made-devices

5. Person Responsible for Regulatory Compliance

Manufacturers of custom-made devices shall have available in their organisation at least one person responsible for regulatory compliance (PRRC). Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/devices-for-special-purposes/custom-made-devices

6. Labelling Requirements

The devices shall be labelled with “custom-made device”. The devices shall not bear the CE marking. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/devices-for-special-purposes/custom-made-devices

7. Post-Market Follow-Up Requirements

The manufacturer must fulfil the following points in their follow-up of custom-made devices that are placed on the market: a periodic safety update report shall be part of the documentation, reporting of serious incidents and corrective safety measures, and clinical follow-up after the device has been placed on the market. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/devices-for-special-purposes/custom-made-devices

8. Devices Not Considered Custom-Made

Mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person are not considered custom-made devices. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/devices-for-special-purposes/custom-made-devices

9. Contact

For further information contact NoMA Units for medical devices at +47 22 89 77 00 or meddev-no@noma.no. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/devices-for-special-purposes/custom-made-devices