This new Starodub white paper, of May 2021, focusses on the legislative aspects of combination products in relation to both the EU Medical Device Regulation (MDR) and the amendment of the EU Directive 2001/83/EC. The paper discusses the implications of the new regulations for combination products from a medical device and pharmaceutical perspective. With the introduction of the new Regulation dealing with combination products in the EU has become clearer but at the same time a lot of questions are raised.
Upon reading this paper you will learn the reasons and consequences for combination products in the MDR era.