Earlier this month, the European Commission published a “rolling plan” for the implementation of the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). As we mentioned in our blog from last year, CAMD’s (Competent Authorities for Medical Devices) Implementation Taskforce published a high-level MDR/IVDR roadmap setting out how the Regulations will be implemented, and the order in which key guidance and clarification will be developed. Now, the Commission has published the rolling plan, which contains a list of the essential implementing acts and actions that need to be introduced, as well as providing information on expected timelines and the current state-of-play.

Continue Reading Update on the European MDR and IVDR

On 26 May 2017, the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) entered into force. In order to aid preparations for the provisions taking effect, the Medicines and Healthcare products Regulatory Agency (MHRA) has published materials to help manufacturers understand the new requirements, and in particular, has published an introductory Interactive Guide to the Regulations. The MHRA’s director of Medical Devices, John Wilkinson, explained that “We live in an increasingly digital world, and the way we provide our guidance is changing. We want to help manufacturers to comply with the new regulations as easily and as early as possible.”

The Interactive Guide allows users to navigate through key topics and provides a high level overview of the Regulations for manufacturers who may be looking at them for the first time, and also seeks to help experienced manufacturers navigate the changes. A brief summary of the key points is set out below.

Continue Reading MHRA’s guide to the new EU Medical Devices Regulations