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Technical standards of electromedicals: between old directives and new regulation

Regolamento Elettromedicali

One of the characteristics defining the healthcare medical devices is the high impact of technological factors. Regardless the technological level of a medical device, mechanic, electrical, electronic, information elements as well as others are commonly present. This peculiarity has imposed that the legislator takes into account the prescriptive will to fix minimum safety limits and the need not to bind further the freedom of technical and scientific progress at the base of any practical solution that a medical device represents for a specific problem. Such is the impact of this aspect, that article 5 of Directive 93/42/ECC, i.e. the basis of the current regulation framework, has already included the introduction of harmonized norms by which the manufacturers have the possibility...

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Sell ​​food supplements on Amazon

Integratori Amazon

Marketing a food supplement in Italy and in other Member States of the European Union requires the compliance with the relevant European regulations as well as with the local legislation in force on the concerned country. These provide for that the product only contains admitted ingredients, that the relevant labels are adequately prepared in compliance with the regulations and that are therefore notified to the Competent Authority, where required. This regulatory need must be complied with even in the case of food supplements that are marketed on line, for instance on websites like Amazon. In latest years, in fact, with the increased use of the web, more and more companies have decided to sell their food supplements on Amazon. This type of...

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