This guide has been prepared for micro, small and medium sized enterprises ('SMEs') operating in the pharmaceutical sector. Its aim is to facilitate understanding of the main aspects of medicinal product legislation. The guide is structured to follow the chronological stages of developing a...

Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation - MDR) regulates the reprocessing of single-use devices (SUDs) with relevance for the European Economic Area (EEA) which may only take place where permitted by national law and in accordance with this article. This study evaluates...

The Governance Regulation sets out the legal requirements and specific content for Member States (MSs) to report to the EC on the five dimensions of the Energy Union, including when to report and templates for the reports, which are further detailed in Commission Implementing Regulation (EU)...

According to the new Batteries Regulation, requirements for performance and durability shall be successively implemented for rechargeable industrial and light means of transport batteries. This report sets a basis for the design of minimum requirements to ensure minimum battery durability on the...

Article 13 of Regulation (EU) 2019/631 requires the type-approval authorities to verify the CO2 emission and fuel consumption values of light-duty vehicles in-service. Commission Delegated Regulation (EU) 2023/2867 sets out the guiding principles and criteria for defining the procedures for that...