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.
Special note: 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
- Comply with the essential requirements (MDD 93/42/EEC Annex I, AIMDD 90/385/EEC Annex 1);
- Technical documentation (MDD 93/42/EEC Annex VIII Point 3.1; AIMDD90/385/EEC Annex Point 6) ;
- Vigilance system;
Non-EU Manufacturer appointing an Authorized Representative in Europe;
Notification the Competent Authority of the intention of placing a Custom Made device onto the European Market ( MDD 93/42/EEC Article 11 (6));
Custom-made devices do not require the intervention of a Notified Body.
The directive portrays European Law enforced within the European Economic Area (EEA); non-compliance with the directive’s requirements will result in the removal of the device from the EEA. (MDD 93/42/EEC Annex VIII (5));