On 5 December 2017, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a Post-implementation Review of the Human Medicines Regulations 2012 (the Review). The Review assesses the effectiveness and impact of the Human Medicines Regulation 2012 (the 2012 Regulations), which were introduced in the UK with a view to implementing a series of EU directives and to consolidate UK medicines legislation. The Review also sets out recommendations about how to address shortcomings identified in the 2012 Regulations.

Based on the Review, the 2012 Regulations are to be retained and it seems that no major overhaul of these Regulations is to be expected. However, there are likely to be several pieces of guidance issued by the MHRA in the near future in relation to those aspects of the 2012 Regulations that have proved most controversial (e.g., on cross-border prescriptions and wholesale dealing). It is hoped that these will provide welcome clarification. In addition, measures intended to ease the burden for manufacturers of generic medicinal products in relation to the maintenance and distribution of Risk Management Plans and Risk Minimisation Measures may be introduced shortly. The suggestion made by the MHRA in the Review is that work-sharing should be “encouraged” as between marketing authorisation holders, although some respondents to the consultation have suggested that work-sharing should be mandatory. It remains to be seen how, and in what form, the MHRA chooses to introduce any such new measures.

Our advisory, discussing this further, can be found here.

Last month, the UK MHRA published new guidance on human factors and usability engineering for medical devices to be taken into account when designing medical devices in accordance with the regulatory framework. ‘Human factors’ refer to how a person interacts with a product, and will depend on, among other things, the design of the product, the education and training of the intended user population, the environment in which they will be using the product, competing distractions, usability and ergonomics.

Continue Reading MHRA guidance on human factors for medical devices

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