Custom made devices

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

Step 1. 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);

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;

Step 2.

Authorized Representative in Europe

Step 3.

MDD 93/42/EEC Annex VIII Point 2.1

AIMDD 90/385/EEC Annex 6 Point 2.1

Step 4.

European Market

MDD 93/42/EEC Article 11 (6)

do not bear the CE marking

MDD 93/42/EEC Article 17 (1)

AIMDD 90/385/EEC Article 12 (1)

Non-Compliance