performance
as defined in Regulation (EU) 2017/745 of the European Parliament and of the Council of 5…, Article 2, point (22) (Definitions)
the ability of a device to achieve its intended purpose as stated by the manufacturer
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Also defined in
- Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data… 32025R0327, Article 2(1), point (e)
laid down in Article 2, points (1), (12), (14), (22), (36) and (71), respectively, of Regulation (EU) 2017/745 - 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