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
Medical Devices
MHRA’s guide to the new EU Medical Devices Regulations
By Hannah Kerr-Peterson & Arnold & Porter on
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
Advocate General’s opinion on software as medical devices
By Arnold & Porter on
Posted in Medical Devices, software
On 28 June, the Advocate General of the Court of Justice of the European Union gave his opinion on the SNITEM and Philips France case against France. In this case, the Conseil d’Etat in France asked whether a particular software programme intended to be used by doctors to support prescribing decisions falls within the definition of medical device as provided by Directive 93/42/EEC (Medical Devices Directive).