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Answer three questions about your device and see which post-market surveillance reports Regulation (EU) 2017/745 requires, how often they must be updated and who receives them. Every result cites the article it comes from.
The results update as you answer.
Risk class
Is it an implantable device?What counts?
Any device, including those that are partially or wholly absorbed, which is intended to be totally introduced into the human body, or to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure. (Art. 2(5))
Is it a custom-made device?What counts?
A device specifically made in accordance with a written prescription of an authorised person, giving specific design characteristics, and intended for the sole use of a particular patient. Mass-produced devices that need to be adapted to a professional user's specific requirements, and devices mass-produced by industrial processes in accordance with written prescriptions, are not custom-made. (Art. 2(3))
