The Medical Devices Directive
and the Active Implantable Medical Devices Directive
define the "custom-made device" as any device which is specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics. A custom-made device is intended for the sole use of a particular patient. (MDD 93/42/ EEC Article 1 (2) (c)
; AIMDD 90/385/EEC Article 1 (2) (d))
- Examples of qualified medical practitioners: Dentist, Ophthalmologist, Orthotist, Ocularist.
- Example of custom-made devices: Orthopaedic footwear, Maxillofacial Prosthesis.
mass-produced devices which need to be adapted to meet the requirements of a healthcare professional, even though they are supplied for the sole use of a particular patient, are not considered as custom-made. (e.g., contact lenses).
Steps to place a custom-made device on the EU market
Compliance with all the essential safety & health requirements that apply to the device (see compliance with the MDD 93/42/EEC
or compliance with the AIMDD 90/385/EEC