Adaptable medical devices

These devices are not custom-made devices, even though each one ends up fitted to a patient. The adaptation follows the manufacturer's validated instructions, so the device goes through the normal conformity assessment rather than the custom-made route.

Adaptable medical devices (products which fall under (a) above) are mass-produced medical devices which must be adapted, adjusted, assembled or shaped at the point of care, traditionally by a healthcare professional, in accordance with the manufacturer’s validated instructions to suit an individual patient’s specific anatomo-physiologic features prior to use.

MDCG 2021-3, Question 1, Note 1