UK’s Medical Device Post-market Surveillance Statutory Instrument Laid Before Parliament – What are the Key Changes for Medical Device Regulation

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which are supplemented by MHRA guidance (which is based on European Commission MEDDEV guidance applicable to the now repealed EU Medical Devices Directive 93/42/EEC).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:

• More detail on what must be included as part of a manufacturer's PMS system. For example, a PMS system must "include[…] the analysis of data relevant to the quality, performance and safety of the device throughout its lifetime".Additionally, the PMS system must be based on a PMS plan, which must specify processes for the collection and assessment of data, including PMS data on similar devices available within and outside the GB market, and processes to investigate complaints and analyse feedback.
• A requirement for manufacturers of low-risk medical devices to produce a PMS Report ("PMSR") every three years. Manufacturers of medium and high-risk medical devices are required to produce a more detailed Periodic Safety Update Report ("PSUR") annually or every two years, depending on the classification of the device.
• Enhanced obligations for manufacturers to report "serious incidents" promptly to the MHRA.
• A more stringent requirement for manufactures to monitor trends in the frequency or severity of incidents involving their devices, including a duty to submit a report with more detailed information to the MHRA (i.e., "trend reporting").
• Clear obligations on manufactures to take the necessary preventive or corrective actions as soon as possible to reduce a risk that compromises a device's performance or safety, or correct a device's non-conformity. Before taking any field safety corrective action ("FSCA"), a manufacturer must produce a risk assessment and submit to the MHRA (i) an initial report, and (ii) the proposed field safety notice setting out certain required details, including, (a) the identity of the devices involved, (b) an explanation of the reasons for the FSCA with reference to the risks to any person, and (c) a description of all actions to be taken by users in response. The manufacturer must take all reasonable steps to ensure the field safety notice is sent to the users of the device.

The draft PMS SI largely reflects the EU PMS requirements contained in the EU MDR and EU IVDR. However, there are also several differences from the EU legislation, including divergence in the definition of terms such as "corrective action," "preventive action," and "incident." The UK PMS Regulations will also require companies to report any Corrective and Preventative Actions ("CAPAs") related to a device to both the UK Responsible Person and UK Approved Body for that device. In places, the draft PMS SI introduces more detailed and more stringent PMS requirements for medical devices on the GB market, which may require manufactures to adapt their current PMS policies. The industry has also expressed concern as to the potential increased cost of compliance with these new PMS requirements.

What's Next?

While the PMS SI makes its way through Parliament, the Government's next step in updating the regulatory framework for medical devices in the UK is likely to be the introduction of a pre-market statutory instrument ("Pre-Market SI") next year. The Pre-Market SI will seek to improve patient safety by introducing measures such as:

• Increasing the classification and level of scrutiny of certain medical devices;
• Introducing a legal requirement for unique device identifiers;
• Adding a requirement for patients to be provided with information cards alongside implantable medical devices; and
• Introducing new rules on what can be claimed publicly about a device.

In an update last month, the MHRA noted that "[w]hilst the improvements to patient safety in [the Pre-Market SI] […] will be in line with our 2021 consultation, the measures to improve access go further, so we will need to consult on them." The MHRA's ambition is to complete this consultation by the end of 2024. The consultation will cover:

• International reliance and recognition;
• Changes to the regulation of in vitro diagnostic devices ("IVDs"), which adopt a risk proportionate approach to the regulation of IVDs;
• Clarification of the meaning of software and the use of pre-determined change control plans for software/AI devices; and
• Flexibility for requirements for physical UKCA markings on devices and packaging.

Covington will continue to follow developments and provide further updates. If you would like to discuss the upcoming changes to the regulatory framework for medical devices in the UK and what it may mean for your company's operations, please contact our specialist UK and EU medical device regulatory team.