performance
as defined in Regulation (EU) 2024/3110 of the European Parliament and of the Council of 27…, Article 3, point (6) (Definitions)
the degree to which a product has certain scalable essential characteristics
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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) 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