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The MHRA is continuing to publish details on how software and AI medical devices will be regulated in the UK post Brexit, with the aim of making the UK an attractive place to launch such products. The MHRA’s recent updates to its ‘Software and AI as a Medical Device Change Programme’ (the Change Programme) intend to “deliver bold steps to provide a regulatory framework that provides a high degree of protection for patients and public, but also makes sure that the UK is recognised globally as a home of responsible innovation for medical device software looking towards a global market.”

The MHRA has also recently announced it will extend the period during which EU CE marks on medical devices (including for software) will be accepted on the UK market, until July 2024.

We set out an overview of these updates below.Continue Reading Latest on software and AI devices from the MHRA

On 14 July 2022, the European Commission published a proposal for a Regulation on the safety and quality of substances of human origin (SoHO) intended for human application. When adopted, the proposed Regulation will repeal and replace the currently applicable Directive 2002/98/EC on blood (the Blood Directive) and Directive 2004/23/EC on tissues and cells (the Tissue and Cells Directive), with the aim of reforming and modernising the existing EU legislation. The proposal sets out requirements and standards for the safety and quality of blood, tissues, and cells (BTC), as well as other SoHOs, through a single instrument that will apply in all EU Member States in a (hopefully) harmonised manner.

This will be a major development for life sciences companies operating in the EU, including companies developing advanced therapy medicinal products (ATMPs, such as cell and gene therapies) manufactured from or using SoHOs. The Regulation will apply from donation to human application, unless the SoHOs are used in the manufacture of medicinal products or medical devices, in which case the Regulation will apply to donation, collection and testing of the substances only. A public consultation is open until 8 September 2022, and the proposal will also be discussed by the Council and the European Parliament. Once the final text is agreed and adopted, it will come into force, with the proposal setting out a 2-year or 3-year transition period depending on the provision.Continue Reading EU Commission adopts Proposal for a Regulation on substances of human origin

There is currently no specific legislation in the UK that governs AI, or its use in healthcare. Instead, a number of general-purpose laws apply. These laws, such as the rules on data protection and medical devices, have to be adapted to specific AI technologies and uses. They sometimes overlap, which can cause confusion for businesses trying to identify the relevant requirements that have to be met, or to reconcile potentially conflicting provisions.

As a step towards a clearer, more coherent approach, on 18 July, the UK government published a policy paper on regulating AI in the UK. The government proposes to establish a pro-innovation framework of principles for regulating AI, while leaving regulatory authorities discretion over how the principles apply in their respective sectors. The government intends the framework to be “proportionate, light-touch and forward-looking” to ensure that it can keep pace with developments in these technologies, and so that it can “support responsible innovation in AI – unleashing the full potential of new technologies, while keeping people safe and secure”. This balance is aimed at ensuring that the UK is at the forefront of such developments.

The government’s proposal is broadly in line with the MHRA’s current approach to the regulation of AI. In the MHRA’s response to the consultation on the medical devices regime in the UK post-Brexit, it announced similarly broad-brush plans for regulating AI-enabled medical devices. In particular, no definition of AI as a medical device (AIaMD) will be included in the new UK legislation, and the regime is unlikely to set out specific legal requirements beyond those being considered for software as a medical device. Instead, the MHRA intends to publish guidance that clinical performance evaluation methods should be used for assessing safety and meeting essential requirements of AIaMD, and has also published the Software and AI as a medical device change programme to provide a regulatory framework with s a high degree of protection for patients and public.Continue Reading UK Policy Paper on regulation of AI

On 26 June 2022, the MHRA published the UK Government’s response to the consultation on the regulatory framework for medical devices in the UK (the Response), and following analysis of the nearly 900 responses received, its intentions for the future UK regulatory regime for medical devices (the UK Regulations).

In September 2021, we posted about the MHRA’s consultation, with a summary of the proposals set out across 15 technical chapters.  The consultation ran between September and November 2021, and focused on patient safety and innovation, whilst recognising that gaining and maintaining competitiveness in a global market will be best supported by aligning with internationally recognised best practice and standards.

We have considered the Response and set out some of the key factors we consider to be of particular interest below. We have not precisely follow the order in the Response and have not covered every aspect or changes; this is necessarily a high level summary.

While the approach the MHRA intends to take in the UK Regulations is clarified and set out in more detail in the Response, no draft statutory text has yet been published. A lot of detail will also be left to guidance that will accompany the UK Regulations. It will therefore be important to see how closely aligned the new UK framework is to the proposals described in the Response and with international rules and standards.Continue Reading MHRA response to consultation on the regulation of medical devices

In September 2021, we posted about the European Commission’s implementation of its new pharmaceutical strategy (which was also discussed in more detail in our posts on the strategy, proposed amendments to orphan and paediatric legislation and the industry response). Readers will be aware that the focus of the Strategy is on the availability, accessibility and affordability of medicinal products, based on the view that current incentive models do not provide an adequate solution for unmet medical needs or appropriately incentivise investment in innovation. As part of its work on the revision of the EU pharmaceutical legislation, the European Commission launched a public consultation to seek views on the current framework and on some of the proposals for changes in order to support the European Commission’s impact assessment for the revision of the legislation.

Following this consultation, the European Federation of Pharmaceutical Industries and Associations (EFPIA) published an article entitled “Back Innovation, Boost Access” with its response to the EU pharmaceutical strategy consultations and some of the concerns raised by the Commission. This expresses EFPIA’s position that innovation is only meaningful if patients have access to it, but highlights that access is not always in the control of the pharmaceutical companies. It also describes the current status of access to medicines in the EU Member States, some of the reasons for the delays to access and EFPIA’s proposals to improve patient access to innovative medicines.Continue Reading EFPIA’s Response to EU Pharmaceutical Strategy Consultations

Following increasing pressure from industry and patient groups alike, yesterday (14 October) the European Commission published its proposal to delay the application of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) by amending the transitional provisions for certain products. The Commission noted that the COVID-19 pandemic has hampered the capacity of Member States, health institutions and companies to comply with the new requirements in time for the current deadline of May 2022, and that the “serious shortage of notified body capacity, mak[es] it impossible for manufacturers to conduct the legally required conformity assessment procedures in time”. As such, the proposal provides industry and patients some much needed relief, and aims to avoid a large number of products that are already on the market being discontinued in May due to non-compliance.

While the proposal still needs to go through the EU legislative procedure, it seems likely that the amendment will be adopted before the current date of application of May 2022. It is also important to note that the delay does not apply uniformly to all IVDs, as set out below.Continue Reading European Commission proposal to delay application of In Vitro Diagnostics Regulation

On 28 September 2021, the European Commission took another step in the implementation of its  new pharmaceutical strategy (discussed in more detail in our previous blog posts on the strategy, proposed amendments to orphan and paediatric legislation and the industry response).

As part of its work on the revision of the EU pharmaceutical legislation, the Commission launched a dedicated public consultation. The purpose of this consultation is to gather views and information to support the Commission’s impact assessment for the revision of the EU pharmaceutical legislation. This is, therefore, a good opportunity for all stakeholders to share their views and concerns, as well as their vision for the future EU pharmaceutical legislation.

The consultation is open until 21 December 2021 and seeks the views of all stakeholders on key issues such as:Continue Reading European Commission launches consultation on reform of EU pharmaceutical legislation

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.Continue Reading Consultation on framework for medical devices in UK

We discussed in previous posts the Commission’s announcement at the end of 2020 of its new pharmaceutical strategy for the EU. One topic identified as in need of revision was the unmet medical needs in areas currently not within the scope of the legislation governing rare diseases and paediatric medicines.  We have previously discussed recent consultations and stakeholder engagements by the Commission to explore possible changes to the legislative regime in these areas, including the possibility of reducing the ten-year market exclusivity period for orphan medicines and changing the criteria for determining the rarity of a disease.

Following the responses to these consultations, in May 2021, the Commission launched its latest public Consultation on the proposed revisions to the legislation.  The Commission’s statement accompanying the launch asserts that its evaluation “revealed shortcomings in the current system concerning in particular the development of medicines in areas of high unmet need for patients and their accessibility to all EU patients across the Member States.” Industry bodies representing the innovative pharmaceutical industry have now published their responses to the Consultation, as summarised below.
Continue Reading Industry’s response to the Commission’s proposed amendments to the EU orphan and paediatric legislation

As we have discussed in previous posts, at the end of 2020, the European Commission set out its vision to build a European Health Union with its announcement of the new pharmaceutical strategy for Europe (the new Strategy). In 2021, the Commission has begun to implement the new Strategy, as discussed here. One area that was identified as in need of revision was the unmet medical needs in areas currently not within the scope of the legislation governing rare diseases and paediatric medicines. The Commission has been focused on this area for a number of years, and there have been a number of consultations and stakeholder engagements to explore possible changes to the legislative regime. We set out below a summary of the Commission’s proposals on orphan and paediatric medicinal products.

Continue Reading European Commission’s proposed amendments to orphan and paediatric legislation