performance
as defined in Regulation (EU) 2025/327 of the European Parliament and of the Council of 11…, Article 2(1), point (e) (Definitions)
laid down in Article 2, points (1), (12), (14), (22), (36) and (71), respectively, of Regulation (EU) 2017/745
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Also defined in
- Regulation (EU) 2024/3110 of the European Parliament and of the Council of 27 November 2024 laying down harmonised… 32024R3110, Article 3, point (6)
the degree to which a product has certain scalable essential characteristics - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending… 32017R0745, Article 2, point (22)
the ability of a device to achieve its intended purpose as stated by the manufacturer