The EU Medical Devices Regulation (MDR, 2017/745), which came into force in May 2017, must be implemented by 26th May 2020. So far, only five Notified Bodies are able to certify products under the new regulation. As far as we know, only two products have been CE certified under MDR, one being BSI for [...]
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So far Emilie-Marie Vieuble has created 127 blog entries.
In the food sector, plant proteins are widely used both in conventional and in organic markets. Although animal protein consumption is increasing at global level, the EU is seeing the emergence of low animal protein diets. Recent changes across some EU countries suggest the beginning of a shift back towards plants and to less [...]
We dedicate this October issue to the protein paradigm shift and to a potential MDR Corrigendum. Also, meet us next week at CPhI in Frankfurt! […]
Negative feedback from EFSA on the safety of leaf powder of Moringa stenopetala and of powder or juice concentrate of berries of Aristotelia chilensis
Following a notification of leaf powder of Moringa stenopetala as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283 (Novel Food Regulation), EFSA was asked by the European Commission whether there are safety objections to the notification. EFSA found, due to the lack of information regarding the quality [...]
For the last 10 years, EFSA has been evaluating/updating the values for macronutrients such as proteins and carbohydrates, as well as 14 vitamins and 13 minerals. EFSA’s latest scientific opinion about dietary reference values (DRVs) was published this month, setting the DRVs for sodium and chloride. DRVs is an umbrella term for science-based nutrient reference values for [...]
We dedicate this September issue to the end of EFSA’s evaluation of Dietary Reference Values (DRVs) for macronutrients and two safety objections by EFSA for traditional foods from a third country. […]
Act now and get the most of it! Keep your substance-based medical devices in your portfolio with the support of analyze & realize
Background – What changed from MDD to MDR? What are the main implications for substance-based medical devices? In May 2017, the Medical Device Regulation (EU) 2017/745 (MDR) entered into force, replacing the old Medical Decide Directive (MDD; 93/42/EEC medical devices). So theoretically, for a time period of 3 years following the entry into force [...]
We dedicate this August issue to how to keep your substance-based medical devices on the market. We can support you! […]
Let's meet at Vitafoods Asia – Booth P18! Vitafoods Asia is the No. 1 nutraceutical trade show in Asia, bringing together science, business, and government agencies. If you are planning to be in Singapore between the 25th and 26th of September, meet our team of experts at booth P18 during Vitafoods Asia. [...]
Under EU regulations, any food that was not consumed “significantly” prior to May 15, 1997 is considered to be a Novel Food (EU) 2015/2283) and requires a pre-market authorization. According to the Novel Food Regulation, two types of applications – for “typical” Novel Foods (Article 10) and for traditional foods from third countries (non-EU) [...]