MDCG: Guidance on custom-made medical devices according to MDR

The Medical Device Coordination Group (MDCG) published an eight-page Q&A document titled Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices (MDCG 2021-3) on 15 March 2021.

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).  

How are custom-made devices (CMDs) defined under the MDR?

• They are specifically manufactured as prescribed by an authorized person under national law and based on their qualification.  
• They have specific design characteristics provided by the responsible authorized person.  
• They are intended for the exclusive use by a particular person to meet their individual conditions and needs.

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.

Source:

MDCG: Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices