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Memo combination custom made and CE devices 

Certfied prosthetists are typically buying different prosthetic components and put them together for each patient, of course following the instructions for use for each component.

With the coming into force of the European Medical Device Regulation numerous questions have been brought to our attention on the regulatory status of an assembled prosthesis (including e.g. a custom made socket) and the role and responsibilities of the prosthetist, who assembles the prosthesis. This memorandum discusses various scenarios in that context and addresses the regulatory implications of the relevant MDR provisions. It concludes that:

  • A prosthetist assembling a Prosthesis from CE marked components and a custom-made socket, verifying that all are made for the intended purpose of being parts of a prosthetic system, does not need to take regulatory responsibility of the whole prosthesis as a manufacturer, neither as a system placed on the market nor as custom made device, but just as a health care professional assembling and putting the prosthesis in use (fitting it) on the patient, much like a surgeon placing an artificial hip joint in a patient.
The assembled prosthetic system does not gain a medical device regulatory status as being put on the market by being assembled from CE marked and custom-made components intended for such assembly and use. Including components of different medical device classes (I-III) changes nothing about the above as long as their intended purpose and use is not changed.
Dr. Stefan Menzl, PhD
Veröffentlicht am:: November 15, 2021
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