UKCA product marking - 18/12/2024

New medical device marking requirements and regulations in Great Britain

Since Brexit, additional regulations for medical devices have come into effect in Great Britain, i.e. England, Wales and Scotland. Although the transition periods have been extended, medical device manufacturers should familiarise themselves with the new conformity marking requirements. EU medical device regulations will continue to apply in Northern Ireland.

At the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB, a three-dimensional skin model has now been set up for the first time that directly displays the skin's reaction to substances: The reporter skin. Thanks to the built-in reporter, the cellular response can be measured precisely and quickly – using a living model.

Germany has the most active market, Southern Europe wants more variety, and people in Poland find dairy substitutes too expensive, according to a recent study by the University of Hohenheim.

So far, 4.2 million animal tests under the REACH chemical regulation: A study from Konstanz and Baltimore quantifies the number of animals that died for the hazard assessment of chemicals in the chemical industry.

The recently established ITCC-P4 gGmbH provides academic institutions and pharmaceutical companies with a comprehensive repertoire of modern laboratory models of pediatric tumors. The aim is to systematically test new treatment options for children and adolescents with cancer and to contribute data to regulatory approval processes in order to make the development of new cancer therapies for children and adolescents more attractive.

Today, the EU Parliament adopted the EU Regulation on Health Technology Assessment (HTA), which includes not only new medicines (including gene and cell therapies), but also medical devices.