IVDD Other
Spanish translation: producto sanitario de diagnóstico in vitro, otro
| 23:52 Jul 8, 2020 |
| English to Spanish translations [PRO] COVID-19 - Medical - Medical: Instruments / IVDD Other | |||||||
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|  Selected response from: Chema Nieto Castañón Spain Local time: 09:01 | ||||||
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| 3 +2 | producto sanitario de diagnóstico in vitro, otro |
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Answers
29 mins confidence: 
peer agreement (net): +2
peer agreement (net): +2producto sanitario de diagnóstico in vitro, otro Explanation: IVD (in vitro diagnostic medical device) se leería como producto sanitario de diagnóstico in vitro. Por otro lado, la IVD Directive es la norma que regula (que regulaba hasta 2017) a nivel europeo los productos sanitarios de diagnóstico in vitro (Directiva 98/79/CE; actualmente regulado bajo el Reglamento (UE) 2017/746 del Parlamento Europeo y del Consejo, de 5 de abril de 2017, sobre los productos sanitarios para diagnóstico in vitro. Ver último enlace). Así, IVDD sería la Directiva (europea) sobre productos sanitarios de diagnóstico in vitro. De todas formas, en este caso en particular, en tanto que clasificación del producto, me parece discretamente más natural la referencia a IVD Other (producto sanitario de diagnóstico in vitro, otro) que a la normativa que regula este tipo de productos, a pesar de la mención explícita a la misma más abajo. Podría entenderse como un typo en tanto que IVD se refiere a in vitro Diagnostic medical Devices. A medical device is an in vitro diagnostic medical device (IVD) if it is a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic goods for in vitro use. It must be intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, solely or principally for the purpose of giving information about a physiological or pathological state, a congenital abnormality or to determine safety and compatibility with a potential recipient, or to monitor therapeutic measures. https://www.tga.gov.au/ivd-medical-devices-definitions-links many manufacturers are using the humanitarian derogation route which is included in both the IVD Directive and the IVD Regulation to cover this type of emergency. The details are described in Article 9 of the IVDD https://www.qservegroup.com/eu/en/i590/expectations-for-the-... Productos sanitarios para diagnóstico in vitro https://www.aemps.gob.es/productos-sanitarios/productossanit... Reglamento (UE) 2017/746 del Parlamento Europeo y del Consejo, de 5 de abril de 2017, sobre los productos sanitarios para diagnóstico in vitro y por el que se derogan la Directiva 98/79/CE y la Decisión 2010/227/UE de la Comisión (DO L 117, de 5.5.2017, p. 176). (98/79/EC) https://www.aemps.gob.es/productos-sanitarios/prodsanitarios... https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02... |
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