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 […]
This is a brief overview of the most important points regarding Post Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF). Post Market Survey (PMS) Definition PMS (Post Market Survey) refers to all activities carried out by manufacturers, in collaboration with other Economic Operators*, to establish and keep up to date a systematic proactive data collection […]
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” […]
Medical Devices Categorization in Europe Medical Devices are categorized in the European Union in 4 classes: Class I, Class IIa, Class IIb and Class III. Class I being the lowest risk ones and Class III the highest risk ones. There are also 3 “subclasses” in the Class I category: Class I provided in sterilized condition […]
