reg 20 Interpretation of Part III
(1) In this Part ...— “custom-made device” means an active implantable medical device that is— manufactured specifically in accordance with a medical specialist’s written prescription which gives, under his responsibility, specific characteristics as to its design; and intended to be used only for a particular patient; and “relevant device” shall be construed in accordance with regulation 21. (2) In this Part ..., a reference to a numbered ... Annex is to the ... Annex of Directive 90/385 bearing that number.