Custom Made Medical 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
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;
Non-EU Manufacturer appointing an Authorized Representative in Europe;
Draw up a statement concerning the custom-made device (MDD 93/42/EEC Annex VIII Point 2.1; AIMDD 90/385/EEC Annex 6 Point 2.1);
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 bear the CE marking. (MDD 93/42/EEC Article 17 (1); AIMDD 90/385/EEC Article 12 (1)) ;
Custom-made devices do not require the intervention of a Notified Body.
- The Directive: MDD 93/42/EEC
- Technical File
- Notified Body under the MDD
- Authorized Representatives under the MDD
- Custom Made Medical Devices
- Clinical Investigation
- Risks of Non-Compliance
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