MDCG Guidance on MDR custom-made devices

The MDCG issued a dedicated Questions & Answers on the most pertinent matters concerning custom-made devices, adaptable medical devices and patient-matched medical devices as regulated by the MDR  - Regulation (EU) 2017/745.  Below we present an extract from this helpful document, starting with some definitions and examples.

Custom-made devices

Definition: MDR Article 2(3)

‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which . . .

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