What makes your product a cosmetic in the European Union and the United Kingdom During the product’s development phase, brands or manufacturers are often confused about the categorisation. We were contacted more than once by companies with the same question: “Is our product considered a cosmetic or a medicinal product?”. In the most extreme cases, […]
Medical Device
Medical Devices embody a very complex field in Europe, making billions of profit. Varieties and categories are numerous, while their usage is always leading to high stakes involving human safety. All these factors are making the Medical Device framework confusing, especially since it is constantly evolving. The EU is currently deeply modifying its Medical Devices […]
The Borderline Between a Cosmetic Product and a Medical Device One important change in the Medical Device Regulation (EU) 2017/745 (the MDR) is the integration of 6 groups of products in its scope: the “Cosmetic Products” listed in Annex XVI which reads the following: While some products listed are easy to identify, such as “decorative” […]