custom-made device
as defined in Regulation (EU) 2017/745 of the European Parliament and of the Council of 5…, Article 2, point (3) (Definitions)
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 gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices
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Also defined in
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices 31993L0042, Article 1(2), point (d)
any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. The abovementioned prescription may also be made out by any… - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active… 31990L0385, Article 1(2), point (d)
any active implantable medical device specifically made in accordance with a medical specialist's written prescription which gives, under his responsibility, specific design characteristics and is intended to be used only for an individual named patient