UK

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’s (UKG) proposals for new, sector-specific cybersecurity rules continue to take shape. Following the announcement of a Product Security and Telecommunications Infrastructure Bill and a consultation on the security of apps and app stores in the Queen’s Speech (which we briefly discuss here), the UKG issued a call for views on whether action is needed to ensure cyber security in data centres and cloud services (described here).

In recent weeks, the UKG has made two further announcements:

  • On 30 August 2022, it issued a response to its public consultation on the draft Electronic Communications (Security measures) Regulations 2022 (Draft Regulations) and a draft Telecommunications Security code of practice (COP), before laying a revised version of the Draft Regulations before Parliament on 5 September.
  • On 1 September 2022, it issued a call for information on the risks associated with unauthorized access to individuals’ online accounts and personal data, and measures that could be taken to limit that risk.

We set out below further detail on these latest developments.

*****Continue Reading A packed end to the UK’s cyber summer: Government moves forward with telecoms cybersecurity proposals and consults on a Cyber Duty to Protect

On 28 April 2022, the Subsidy Control Bill (the “Bill”) received Royal Assent, becoming the Subsidy Control Act 2022 (the “Act”).  The Act lays the basic framework for the new UK-wide subsidy control regime, which is now expected to come into force in Autumn 2022.  Although the Act primarily addresses…
Continue Reading UK Subsidy Control Bill granted Royal Assent