On 16 September, the MHRA published its long awaited consultation on the regulatory framework that will govern medical devices in the UK. This follows the publication in July of the MHRA Delivery Plan for 2021-2023, which made clear that the MHRA intends to “establish a new medical devices legislative framework for the UK to support safe innovation and ongoing access to products”.

The current framework for medical devices in the UK is set in the Medical Devices Regulation 2002, which implemented the EU Medical Devices Directives. However, the EU regime has now been substantially updated by the Medical Devices Regulations. Whilst the new Medical Device Regulations 2017/745 have been applicable in the EU since 26 May 2021, they do not apply in Great Britain and have not been implemented into UK law. The Regulations will, however, apply in Northern Ireland under the terms of the Northern Ireland Protocol. Similarly, the In Vitro Diagnostic Medical Devices Regulations 2017/746, due to apply in the EU from 26 May 2022, will not apply in Great Britain, but will apply in Norther Ireland.

The MHRA was heavily involved in the development of the new EU legislation and believed in the need to update the current Medical Device Directives and the UK Regulations. There have been concerns that as the updates to the EU regime do not apply in Great Britain, the UK may be seen as a less attractive country in which to develop and market medical devices, or that it does not protect patients to the same extent.

As such, the consultation focuses on patient safety and innovation (which are not mutually exclusive) whilst recognising that gaining and maintaining competitiveness in a global market will best be supported by alignment with internationally recognised best practice and standards, including greater alignment with the new EU Regulations.


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The UK MHRA has issued draft guidance on randomised controlled trials generating real-world evidence (RWE) that is used to support regulatory decisions. It is intended to be the first in a series of guidance documents addressing RWE. The guidance is part of the MHRA’s push to reinforce the view of the MHRA as a pro-innovative regulatory authority, and that the UK is a leading country in which to conduct clinical research, post-Brexit.

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The UK government published its Medicines and Medical Devices Bill (the Bill) on 13 February 2020. The Bill seeks to introduce delegated powers which will allow the Secretary of State to amend or supplement the existing UK regulatory framework for medicines, medical devices, clinical trials and veterinary medicines at the end of the transition period for the UK’s departure from the EU (the Transition Period), which is currently scheduled for 31 December 2020. The Bill also consolidates and expands on the existing UK medical devices enforcement powers and provides for an information gateway to permit sharing of information held by the Secretary of State in relation to medical devices.

Continue Reading UK government publishes new draft legislation on medicines and medical devices

As a New Year present to us all, on 3 January 2019, the MHRA published updated guidance on the regulation of medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019 without a deal, known as a “hard Brexit”.

Following publication of the technical notice in August 2018, which we considered in an earlier blog, a consultation was launched in order to seek views on the mechanics behind some of the proposals. The consultation ended on 1 November 2018; the responses were reviewed and the technical notice updated. However, the notice states in a number of places that further guidance will be published in due course.


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In July, we considered the implications of the UK Government’s Brexit White paper, setting out its proposals for the UK’s ongoing relationship with the EU post-Brexit and how this would apply to the supply and manufacture of medicinal products and medical devices. Acknowledging the need for a contingency plan if no agreement can be reached, the Medicines and Healthcare Regulatory Agency (MHRA) has now published guidance entitled “How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal“. Below, we set out the key points arising from that guidance.

Withdrawal Act

The regulation of medicines and medical devices in the UK is currently subject to both EU and UK legislation and oversight. For example, in relation to medicinal products, Directive 2001/83 and Regulation 726/2004, which govern marketing and supply in the EU, are implemented into UK law by the Human Medicines Regulations 2012 (HMR). For medical devices, Directives 93/42 (on medical devices), 98/79 (on in vitro medical devices) and 90/385 (on active implantable medical devices) set out the regulations in the EU, and are implemented in the UK through the Medical Devices Regulations 2002 (MDR). In addition, the new Regulations 2017/745 (on medical devices) and 2017/746 (on in vitro medical devices) will apply from 2020 and 2022, respectively.

In the event of a no-deal Brexit, full regulatory authority will pass to the UK, and the European legislation will cease to apply to the UK on 29 March 2019 (exit day), although UK legislation that implements EU law will remain in force. Under the EU (Withdrawal) Act 2018 (EUWA), all existing EU rules will be converted into UK law at the moment of exit to the extent they are not already part of UK law.


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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

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.

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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