Ten pairs of questions and answers clarify how to deal with custom-made medical devices with regard to the new Medical Device Regulation (EU) 2017/745 (MDR).
Dental crowns, hand prostheses or orthoses are mentioned as examples.
The Q&A clarifies the extent to which differences exist between custom-made, mass-produced and, for example, 3D-printed medical devices according to the new MDR. For example, manufacturers of "intermediates," which in turn are used to make or are combined with custom-made medical devices, must comply with MDR requirements.
The MDCG is composed of representatives from all European member states, as well as a representative of the European Commission, who serves as chair. Thus, the Q&A is not a European Commission document and as such is not legally binding.