The European medical devices regulation (MDR) 2017/745/EC was published on 5th May 2017 and has updated significantly the requirements for medical devices placed on the European market. It has introduced new requirements for manufacturers to comply with to achieve CE marking before placing their products on the European market. Some of the principal changes are in the areas of the role of economic operators, vigilance and post-market surveillance, increased requirements for clinical evidence and, expansion of the scope of products covered under the regulation when compared with the previous directives. This guide provides some background to the legislative changes with a focus on the requirements in the regulation of what are typically known as drug-device combination products.