(12)
‘medical device’ means both a medical device as defined in Article 2, point (1), of Regulation (EU) 2017/745 of the European Parliament and of the Council (28), read in conjunction with Article 1(2) and Article 1(6), point (a), of that Regulation, and an in vitro diagnostic medical device as defined in Article 2, point (2), of Regulation (EU) 2017/746 of the European Parliament and of the Council (29);
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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.