Custom Made

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);

Step 2:

Non-EU Manufacturer appointing an Authorized Representative in Europe;

Step 3:

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);

Step 4:

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.

Non-Compliance

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));


| Home | Contact Us | Get a Quote |


Follow us:
Facebook

Facebook
Google+

http://obelismedical.net/medical-device-directive-custom-made-devices/
YouTube

YouTube
LinkedIn

RSS
in Medical Devices Directive