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"Self-Care Medical Devices could be an opportunity for only a small selection of the Health Claim products.\r\n\r\nThis means that such a product needs to be re-developed according to Medical Device QMS procedures ISO-13485. In addition a technical file needs to be created according the conformity assessment route including clinical data, biocompatibility data, validation, production records, risk analysis, audit reports, etc. All above needs to be audited by an recognized Notified Body.\r\n\r\nAlso be aware that Simethicone Medical Devices are on the market since early 2000, including isotonic nasal sprays that are still marketed as food supplement today in several european countries.\r\n\r\nAs a result a self-care medical device can use the medical claim (not medicinal claim, that is a pharmaceutical).\r\n\r\nConclusion: Could be an opportunity, but for sure not an escape route...."
<https://www.nutraingredients.com/Article/2013/01/03/EU-medical-devices-route-tempts-article-13-health-claim-losers>