UKCA: the new marking within the UK market
To gain an understanding of the UKCA conformity procedures, it is important to receive an in-depth overview of the basic amendments. Let us briefly outline the post-Brexit effects on the UK market landscape, specifically with regard to product certification for placing products on the GB (Great Britain) market.
CE marking for medical software & Apps
Software and apps that are essential to the proper functioning of a medical device must be CE marked.
What is a toy according to the Toy Safety Directive 2009/48/EC?
Many products can be used in play by children, but that does not mean that all objects fall under the definition of a toy. The Toys Directive describes what a toy is on the basis of a number of criteria.
Medical Devices Regulation 2017/745
Due to COVID-19 the implementation date of Medical Devices Regulation 2017/745 has been postponed until 26 May 2021.