art_2__para_1
1. For the purposes of this Regulation, the following definitions apply: the definitions of ‘personal data’, ‘processing’, ‘pseudonymisation’, ‘controller’, ‘processor’, ‘third party’, ‘consent’, ‘genetic data’, ‘data concerning health’ and ‘international organisation’ laid down in Article 4, points (1), (2), (5), (7), (8), (10), (11), (13), (15) and (26), respectively, of Regulation (EU) 2016/679; the definitions of ‘healthcare’, ‘Member State of affiliation’, ‘Member State of treatment’, ‘health professional’, ‘healthcare provider’, ‘medicinal product’ and ‘prescription’ laid down in Article 3, points (a), (c), (d), (f), (g), (i) and (k), respectively, of Directive 2011/24/EU; the definitions of ‘data’, ‘access’, ‘data altruism’, ‘public sector body’ and ‘secure processing environment’ laid down in Article 2, points (1), (13), (16), (17) and (20), respectively, of Regulation (EU) 2022/868; the definitions of ‘making available on the market’, ‘placing on the market’, ‘market surveillance’, ‘market surveillance authority’, ‘non-compliance’, ‘manufacturer’, ‘importer’, ‘distributor’, ‘economic operator’, ‘corrective action’, ‘recall’ and ‘withdrawal’ laid down in Article 3, points (1), (2), (3), (4), (7), (8), (9), (10), (13), (16), (22) and (23), respectively, of Regulation (EU) 2019/1020; the definitions of ‘medical device’, ‘intended purpose’, ‘instructions for use’, ‘performance’, ‘health institution’ and ‘common specifications’ laid down in Article 2, points (1), (12), (14), (22), (36) and (71), respectively, of Regulation (EU) 2017/745; the definitions of ‘electronic identification’ and ‘electronic identification means’ laid down in Article 3, points (1) and (2), respectively, of Regulation (EU) No 910/2014; the definition of ‘contracting authorities’ laid down in Article 2(1), point (1), of Directive 2014/24/EU of the European Parliament and of the Council (28); the definition of ‘public health’ laid down in Article 3, point (c), of Regulation (EC) No 1338/2008 of the European Parliament and of the Council (29).
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Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.