Article 2Definitions

1. For the purposes of this Regulation, the following definitions apply:

(a)

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;

(b)

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;

(c)

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;

(d)

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;

(e)

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;

(f)

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;

(g)

The article continues in the official text.