HAS. Contribuer à la régulation par la qualité et l'efficience Recherche Avancée Accueil Recherche Avancée Accès directs Scope santé Lettres d'information Abonnez-vousGérez vos abonnements Suivez-nous sur Site Internet mobile © 2015 Haute Autorité de santé. Scientific Opinion of the NDA Panel: Oat beta glucan and lowering blood cholesterol. EFSA Journal 2010;8(12):1885 [15 pp.]. doi:10.2903/j.efsa.2010.1885 Type: Opinion of the Scientific Committee/Scientific Panel On request from: Competent Authority of the United Kingdom following an application by CreaNutrition AG Question number: EFSA-Q-2008-681 Adopted: 12 November 2010 Published: 08 December 2010 Affiliation: European Food Safety Authority (EFSA), Parma, Italy Following an application from CreaNutrition AG submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to oat beta-glucan and “can actively lower/reduce blood LDL and total cholesterol”.
The scope of the application was proposed to fall under a health claim referring to disease risk reduction. The food constituent, which is the subject of the health claim, is oat beta-glucan. Autorité européenne de sécurité des aliments (EFSA) - Engagée depuis 2002 dans la sécurité des aliments en Europe. Medical devices - Medical devices | Public health , European Commission. Register of designated Orphan Medicinal Products (by number) Certification and marketing of medical devices: websites recommended by LNE G-MED. Establishment Registration & Device Listing. Guide on Class III MDD- Medical Devices CE marking (mark) & European (EU) Authorized Representative service. Steps for Class III medical devices compliance Classification: ensure the device is a Class III medical device.Choose Conformity Assessment Route: refer the flow chart below.Compile the Technical File.Obtain certification from a Notified BodyDeclaration of Conformity.Appoint an Authorised Representative.
(Hold the Tech Files for inspection by the Competent Authority)Vigilance and Post Market Surveillance. (affix CE marking & market the products) Class III Medical Devices: Conformity Assessment Routes The conformity assessment routes for Class III Medical Devices There are two routes: FAQ/Q&A: Questions and Answers about CE Marking of Medical Devices About CE Marking: | Home | About Us | Contact Us | Copyright & Disclaimer | Privacy | Log-in | Order Now |