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French translation: directive DM / directives relatives aux dispositifs médicaux
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| 09:47 Dec 28, 2023 |
| English to French translations [PRO] Medical - Medical: Cardiology / étude clinique, stents | |||||||
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|  Selected response from: Moukhamadou Mansour Sine Local time: 11:02 | ||||||
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| 3 +2 | directive DM / directives relatives aux dispositifs médicaux |
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| Discussion entries: 3 | |
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Answers
26 mins confidence: 
peer agreement (net): +2
peer agreement (net): +2| mdd directive DM / directives relatives aux dispositifs médicaux Explanation: It could mean in this context Medical Devices Directive The Medical Device Directive — Council Directive 93/42/EEC of 14 June 1993 concerning medical devices — is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards'[1] have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on 21 March 2010. https://sante.gouv.fr/soins-et-maladies/autres-produits-de-sante/article/les-dispositifs-medicaux-implants-protheses |
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| Reference: see Reference information: Medical Devices Directive https://www.bsigroup.com/globalassets/meddev/localfiles/fr-f... They will also facilitate the management of clinical investigations conducted under the Medical Devices Directive (93/42/ EEC) (MDD) or Active Implantable Medical Device Directive (90/385/EEC) (AIMDD), but continuing under the Medical Device Regulation (2017/745) (MDR), or |
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