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.
Examples of custom-made devices:
- dental equipment, such as crowns and bridges
- orthopaedic devices, such as prostheses and special shoes
- 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, cf. MDR article 52 (8).
- A declaration must be prepared before the device can be sold, cf. MDR Annex XIII (1). This declaration must include, among other things, a statement that the device is intended only for one specific patient or user, which is identified by name, an acronym or a numerical code.
- Manufacturers of custom-made devices shall have available in their organisation at least one person responsible for regulatory compliance (PRRC), cf. MDR article 15. This person must document at least two years of professional experience in a relevant manufacturing area, or meet the requirements in MDR article 15 (1a) or (1 b). (link)
Requirements for labelling
All medical devices must be labelled in accordance with the requirements stated in MDR Annex I, Chapter III. Specific requirements that only apply to custom-made devices:
- The devices shall be labelled with «custom-made device», cf. MDR Annex I, section 23.2 p) and 23.3 g)
- The devices shall not bear the CE marking, cf. MDR article 21
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, cf. MDR Annex XIII
- Reporting of serious incidents and corrective safety measures, cf. MDR Article 87
- Clinical follow-up after the device has been placed on the market, cf. MDR Annex XIV part B
Devices that are not considered custom-made devices
- Mass-produced devices which need to be adapted to meet the specific requirements of any professional user
- Devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person
For more information on custom-made devices see Questions and Answers on Custom-Made Devices & considerations on Adaptable Medical Devices and Patient-matched medical devices.