The European Commission’s (EC) Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR) have been the most significant developments for medical device manufacturers willing to enter the European market. These regulations will allow the EU (European Union) regulators to have the required control and oversight of the medical devices entering into the market.
In the European Union (EU), a cosmetic marketing claim is regulated under EU Regulation (EC No. 655/2013). The Annex III – ‘free from’ claims were added on the July 3, 2017 to the list of regulations to be effective/mandated from July 1, 2019. At the same time the Annex IV ‘hypoallergenic’ claim was introduced.