Q&A on Custom-Made Devices

The European Commission has published a Questions and Answers document for Custom-Made Devices (CMD).  This also outlines considerations on adaptable and patient-matched medical devices. The documents outlines 10 key questions regarding CMDs, including

📢 Key Questions:

(1)    What is a custom-made device (CMD)?

(2)    Can parts, components or materials specifically intended to be used in a custom-made device, adaptable medical device or patient-matched medical device be placed on the market as medical devices according to the MDR?

(3)    Are there specific considerations/requirements which must be taken into account by manufacturers of devices referred to in Question 2?

(4)    Can manufacturers use state of the art industrial manufacturing processes to manufacture CMDs?

(5)    Does a 3D printed device (additive manufacturing) qualify as a CMD?

(6)    What defines a written prescription containing patient specific design characteristics?

(7)    Shall the authorised person referred to in the definition of a CMD be a healthcare professional?

(8)    What are the obligations of CMD manufacturers according to the MDR?

(9)    Which obligations of CMD manufacturers differ from those of other medical device manufacturers?

(10) What are the implications for a CMD manufacturer using CE-marked devices referred to in Question 2 instead of non-CE marked devices?

📚 Documents:

·         MDCG 2021-3  :  https://bit.ly/3w9GHc3