United Kingdom

Last month we provided an update on the UK Government’s draft post-market surveillance statutory instrument (“PMS SI”) and the UK Medicines and Healthcare products Regulatory Agency’s (“MHRA’s”) intention to run a further public consultation on proposed changes to pre-market medical device regulation under an upcoming statutory instrument (“Pre-Market SI”).

On 14 November 2024, the MHRA launched a consultation on proposed pre-market regulatory changes for medical devices and in vitro diagnostic (“IVD”) devices (the “Consultation”).  The MHRA intends to incorporate the feedback from the Consultation in drafting the Pre-Market SI.

The Consultation, which is open until 5 January 2025, addresses four areas of the future regulatory framework for medical devices in Great Britain (“GB”):

  1. International Reliance Scheme
  2. UK Conformity Assessment (“UKCA”) Marking
  3. In Vitro Diagnostic Devices
  4. Assimilated EU Law

It builds on the MHRA’s previous consultation in November 2021 (see our update here) and the responses to that consultation.

In the Ministerial Foreword to the Consultation, the Government makes clear that its reforms to the regulatory framework for medical devices in GB are focused on improving “timely access to high-quality healthcare”.  However, the Government recognises that this aim must be balanced with ensuring confidence in the safety and effectiveness of “groundbreaking medical devices”.

We discuss the four areas of the Consultation below.Continue Reading MHRA Consults on New UK Pre-Market Medical Device Measures

On 21 October 2024, the UK Government laid the draft Post-market Surveillance statutory instrument (“PMS SI”) before Parliament (see the UK Medicines and Healthcare products Regulatory Agency’s (“MHRA’s”) press release here).  Once implemented, the PMS SI will further amend the UK’s Medical Devices Regulations 2002 (“UK MDRs”) by introducing new vigilance requirements for medical devices already on the Great Britain (“GB”) market.  The proposed updates to the UK MDRs seek to bring it into greater alignment with the EU’s Medical Devices Regulation 2017/745 (“EU MDR”) and In Vitro Diagnostic Medical Devices Regulation 2017/746 (“EU IVDR”), whilst also taking advantage of certain opportunities resulting from the UK’s withdrawal from the EU to build on and diverge from this legislation.

The long-awaited draft PMS SI follows the Government’s response in June 2022 to the MHRA’s 2021 consultation on the future regulation of medical devices in the UK.  In January 2024, the Government published its ‘Roadmap towards the future regulatory framework for medical devices’, which set out the intended timeframe for delivery of the future regulatory framework. 

Since the Government’s response in June 2022, reform of the regulatory framework for medical devices has suffered several delays as a result of various factors, including (i) the extension of the transitional periods under the EU MDR and EU IVDR (see our update here) and knock-on impact on UK strategy, (ii) the UK proposals to adopt a new international recognition procedure for device approvals (see our update here), and (iii) a change of government.

The draft PMS SI represents the new Government’s first step in updating the UK’s legal framework for medical devices.  Subject to the PMS SI’s passage through Parliament, the final version is expected to come into force in the summer of 2025.

What are the Key Changes?

Post-market surveillance (“PMS”) requires manufacturers to monitor the safety of a medical device after it has been released on the market, and, where necessary, take appropriate action to prevent or reduce the risk of an identified safety issue.  The current UK MDRs contain high-level provisions relating to PMS, which are supplemented by MHRA guidance (which is based on European Commission MEDDEV guidance applicable to the now repealed EU Medical Devices Directive 93/42/EEC).

The Government hopes the draft PMS SI will improve patient safety by introducing more stringent and clearer PMS requirements for both CE marked devices and UKCA marked devices that are placed on the market or put into service in GB.  To that end, the draft PMS SI introduces the following:Continue Reading UK’s Medical Device Post-market Surveillance Statutory Instrument Laid Before Parliament – What are the Key Changes for Medical Device Regulation?

The UK Government has announced that it intends to introduce the Cyber Security and Resilience Bill (the “Bill”) to Parliament in 2025. Formally proposed as part of the King’s Speech in July, this Bill is intended to strengthen the UK’s cross-sectoral cyber security legislation to better protect the…

Continue Reading What to expect from the UK’s Cyber Security and Resilience Bill (and when)
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This update focuses on how growing quantum sector investment in the UK and US is leading to the development and commercialization of quantum computing technologies with the potential to revolutionize and disrupt key sectors.  This is a fast-growing area that is seeing significant levels of public and private investment activity.  We take a look at how approaches differ in the UK and US, and discuss how a concerted, international effort is needed both to realize the full potential of quantum technologies and to mitigate new risks that may arise as the technology matures.

Quantum Computing

Quantum computing uses quantum mechanics principles to solve certain complex mathematical problems faster than classical computers.  Whilst classical computers use binary “bits” to perform calculations, quantum computers use quantum bits (“qubits”).  The value of a bit can only be zero or one, whereas a qubit can exist as zero, one, or a combination of both states (a phenomenon known as superposition) allowing quantum computers to solve certain problems exponentially faster than classical computers. 

The applications of quantum technologies are wide-ranging and quantum computing has the potential to revolutionize many sectors, including life-sciences, climate and weather modelling, financial portfolio management and artificial intelligence (“AI”).  However, advances in quantum computing may also lead to some risks, the most significant being to data protection.  Hackers could exploit the ability of quantum computing to solve complex mathematical problems at high speeds to break currently used cryptography methods and access personal and sensitive data. 

This is a rapidly developing area that governments are only just turning their attention to.  Governments are focusing not just on “quantum-readiness” and countering the emerging threats that quantum computing will present in the hands of bad actors (the US, for instance, is planning the migration of sensitive data to post-quantum encryption), but also on ramping up investment and growth in quantum technologies. Continue Reading Quantum Computing: Developments in the UK and US

This update focuses on how growing quantum sector investment in the UK and US is leading to the development and commercialization of quantum computing technologies with the potential to revolutionize and disrupt key sectors.  This is a fast-growing area that is seeing significant levels of public and private investment activity.  We take a look at how approaches differ in the UK and US, and discuss how a concerted, international effort is needed both to realize the full potential of quantum technologies and to mitigate new risks that may arise as the technology matures.

Quantum Computing

Quantum computing uses quantum mechanics principles to solve certain complex mathematical problems faster than classical computers.  Whilst classical computers use binary “bits” to perform calculations, quantum computers use quantum bits (“qubits”).  The value of a bit can only be zero or one, whereas a qubit can exist as zero, one, or a combination of both states (a phenomenon known as superposition) allowing quantum computers to solve certain problems exponentially faster than classical computers. 

The applications of quantum technologies are wide-ranging and quantum computing has the potential to revolutionize many sectors, including life-sciences, climate and weather modelling, financial portfolio management and artificial intelligence (“AI”).  However, advances in quantum computing may also lead to some risks, the most significant being to data protection.  Hackers could exploit the ability of quantum computing to solve complex mathematical problems at high speeds to break currently used cryptography methods and access personal and sensitive data. 

This is a rapidly developing area that governments are only just turning their attention to.  Governments are focusing not just on “quantum-readiness” and countering the emerging threats that quantum computing will present in the hands of bad actors (the US, for instance, is planning the migration of sensitive data to post-quantum encryption), but also on ramping up investment and growth in quantum technologies. Continue Reading Quantum Computing: Developments in the UK and US

On 20 February, 2024, the Governments of the UK and Australia co-signed the UK-Australia Online Safety and Security Memorandum of Understanding (“MoU”). The MoU seeks to serve as a framework for the two countries to jointly deliver concrete and coordinated online safety and security policy initiatives and outcomes to support their citizens, businesses and economies.

The MoU comes shortly after the UK Information Commissioner’s Office (“ICO”) introduced its guidance on content moderation and data protection (see our previous blog here) to complement the UK’s Online Safety Act 2023, and the commencement of the Australian online safety codes, which complement the Australian Online Safety Act 2021.

The scope of the MoU is broad, covering a range of policy areas, including: harmful online behaviour; age assurance; safety by design; online platforms; child safety; technology-facilitated gender-based violence; safety technology; online media and digital literacy; user privacy and freedom of expression; online child sexual exploitation and abuse; terrorist and violent extremist content; lawful access to data; encryption; misinformation and disinformation; and the impact of new, emerging and rapidly evolving technologies such as artificial intelligence (“AI”).Continue Reading UK and Australia Agree Enhanced Cross-Border Cooperation in Online Safety and Security

Our December blog, examined the optimism at the end of last year that a way could be found out of the political deadlock that has paralysed the Northern Ireland Assembly for the last two years. As our blog noted, although those hopes did not materialize, the fact that the discussions had reached such an advanced stage suggested that a solution might be found in the New Year.  The announcement by the Democratic Unionist Party (DUP) on 30 January that a Deal had been reached seems to justify that optimism.

A Historical Recap

The 1998 Belfast Good Friday Agreement (GFA) brought an end to 30 years of ‘The Troubles’.  It struck a delicate balance between the competing interests of the Unionist and Nationalist communities in Northern Ireland.  Key to its success was the removal of border infrastructure between Northern Ireland and the Republic of Ireland, and the creation of a Power Sharing Executive (PSE) for Northern Ireland.  The PSE allocates the position of First Minister to the largest political party in Northern Ireland, and the position of Deputy First Minister to the second largest.  Other than the status implied by the titles, there is very little practical difference between the two roles.

Northern Ireland’s parliament, the Stormont Assembly, only actually sat for any extended period of time between 2007-2017, but, until the last set of elections, the DUP had always held the position of First Minister.

Brexit and Northern Ireland

Northern Ireland voted by 56:44 to remain in the EU in the 2016 Brexit referendum.  The Unionist community largely voted ‘Leave’, believing it would consolidate Northern Ireland’s position within the UK; the Nationalist community generally voted ‘Remain’ for the opposite reason. Continue Reading The DUP and The Deal: Power-Sharing Returns to N Ireland

What do you need to know?

Following a call for information earlier this year, the UK’s Competition and Markets Authority (CMA) has now announced the changes it intends to make to its merger review process. The majority of the changes are to the Phase 2 process, which is only encountered in a minority of formal reviews, namely those where the CMA believes the merger could lead to a substantial lessening of competition – at the time of writing, of the 76 merger reviews opened by the CMA since 1 January 2022, only nine (12%) had been referred to Phase 2 (whereas around 10% of non-simplified merger review procedures lead to a Phase 2 review in the EU). These changes largely seek to make the Phase 2 process more interactive, with a view to arriving at acceptable remedies proposals sooner in the process. The proposed changes follow a period of criticism of the CMA’s approach to merger enforcement and reflect a desire to improve the effectiveness of the UK merger review process. The proposed changes are being consulted on until 8 January 2024. 

Why is the CMA revising its Phase 2 procedures?

The amendments are being introduced against the backdrop of the UK’s exit from the EU. Post-Brexit, global deals that could affect competition in the UK and would previously have been the reviewed by the European Commission under its “one-stop-shop” principle are now often reviewed by the CMA in parallel, giving rise to divergent outcomes on clearance or acceptable remedies with surprising frequency. As the CMA’s responsibility has increased, so too has the brightness of the spotlight on its approach to merger enforcement which has also exposed the fact that the EU and UK merger processes are often not in sync. As explained below, some of the CMA’s proposals bring the UK process closer to that of the European Commission, suggesting that limiting (procedural) divergence could be a key driver behind these changes.Continue Reading Towards a More Interactive Merger Review Process: UK CMA Proposes Amendments

From as soon as 1 January 2024, the UK Government is implementing a wide range of new employment law that will affect organizations with UK operations. Below is a handy table summarizing key changes and start dates.

Some critical issues for employers include: (i) stronger workplace protections against sexual harassment; (ii) increased employee flexible working rights; (iii) new holiday pay rules; (iv) new employee rights to request predictable working terms; (v) rights for agency workers to request jobs at client companies; and (vi) changes to TUPE. Continue Reading Eight Imminent Key Changes to UK Employment Law

On 26 October 2023, the UK’s Online Safety Bill received Royal Assent, becoming the Online Safety Act (“OSA”).  The OSA imposes various obligations on tech companies to prevent the uploading of, and rapidly remove, illegal user content—such as terrorist content, revenge pornography, and child sexual exploitation material—from their services, and…

Continue Reading UK Online Safety Bill Receives Royal Assent