The regulations governing medical devices are constantly changing, and today we are witnessing more demanding laws that promote better quality and safety of products.
Medical devices with a valid certificate under one of the previously applicable directives (93/42/EC or 90/385/EEC) on May 26, 2021, can continue to be placed on the market during the validity of this certificate, at the latest until May 26, 2024 under certain conditions.
In the European Union, dietary supplements are regulated as foods. Specific harmonized legislation regulates vitamins, minerals and source substances.
For ingredients other than vitamins and minerals, the European Commission has established harmonized rules to protect consumers from any potential health risks and maintains a list of substances known or suspected to have harmful effects on health.
The European Food Safety Authority (EFSA) is one of the main agencies of the European Union responsible for risk assessment in the field of foodstuffs.
The Directorate General for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF) contributes to the design and implementation of economic policy, ensuring the proper functioning of markets, for the benefit of consumers and businesses.
The decree n°2006-352 of March 20, 2006 requires to declare to the DGCCRF the marketing of dietary supplements. This declaration has a double objective:
– To better know the market in order to facilitate controls,
– To update the positive lists of plants and substances.
All declarations must include legible labelling as well as information allowing the admissibility of the application to be judged with regard to the requirements of Articles 15 and 16.
This declaration is made through a dedicated teleservice: TeleIcare, which allows to directly transmit the declaration of marketing of food supplements to the DGCCRF.
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