What do the 2023 Regs do?

Given the constraints of the powers in the Medicines and Medical Devices Act 2021, the 2023 Regs cannot create freestanding provisions.  Instead, they can only make amendments to the existing regime, as set out in the Medical Devices Regulations 2002 (the UK MDR).  The 2023 Regs therefore add a new Part 4A to the UK MDR which sets out the PMS requirements with which manufacturers must comply.  This new Part 4A will replace the existing PMS requirements which can currently be met by manufacturers complying with the EU regime, as it was amended domestically following the UK’s departure from the EU.

The WTO process

The 2023 Regs are only in draft form, but have been published in order to comply with the UK’s obligations to the World Trade Organisation (WTO) under the Agreement on Technical Barriers to Trade.  That obligation is to provide a minimum period of 60 days during which the WTO and its members can comment on the 2023 Regs.

The Parliamentary process and next steps

Subject to comments from the WTO, the 2023 Regs will still need to be approved by both House of Parliament at a date to be confirmed later this year.  The expected coming into force date for the 2023 Regs is therefore currently scheduled for around June 2024.  The timetable for the implementation of the remainder of the (non-PMS) new GB regulatory regime for medical devices remains unclear, but we would expect an announcement from the UK Government at the same time that the 2023 Regs are laid in Parliament later this year.

What is PMS and when will the requirements apply?

PMS is defined in the 2023 Regs to mean activities that manufacturers proactively carry out, to collect and review experience gained from medical devices placed on the market or put into service.  The core purpose of doing so is to identify whether corrective or preventive actions need to be adopted to address or mitigate concerns identified in the collected and reviewed information.

Many of the PMS requirements apply for the “PMS period”.  That is defined as starting on the date the device is first put into service / placed on the market, and ending at the end of the lifespan of the last device that is put into service / placed on the market.  It’s important to note that the 2023 Regs are prospective only, so they will only apply to devices placed on the market / put into service after the date on which the legislation is commenced (regulation 44ZD).

To which devices will the PMS requirements apply?

The requirements will apply to all general medical devices, active implantable medical devices and in-vitro diagnostic medical devices under the UK MDR, except that the following are expressly carved out and will not be subject to the PMS requirements:

•  devices intended for clinical investigations or performance evaluations, and
• devices that have been granted an exceptional use authorisation by the MHRA in the interests of protecting public health.

Key PMS requirements on manufacturers – systems, plans and reports

The 2023 Regs are notable for the level of detail they prescribe, with which manufacturers must comply when preparing the various systems, plans and reports that are to be required.  The UK Government has opted to give legal weight to the specific detail by including it in the 2023 Regs themselves and not leaving such detail to MHRA guidance.  Manufacturers will need to ensure they have a number of systems and processes in place for each device.  The key ones are as follows:

• A “PMS system” (regulation 44ZE) for each device, the purpose of which is essentially to ensure the collection of relevant data in order to spot trends, identify potential corrective action etc.  The legislation provides a fair degree of discretion to manufacturers to consider what is “proportionate” and “appropriate” for a PMS system, depending on the nature of the device to which it relates.
• A “PMS plan” (regulation 44ZF) upon which the PMS system must be based.  This regulation provides a long and prescriptive list of the processes and information-gathering that must be included in the PMS plan.  For example, there must be a “process for communicating effectively” with the MHRA, Approved Bodies, UK Responsible Persons, suppliers and users of the device.
• A “PMS report” (regulation 44ZL) which must include a summary of the findings from the PMS plan and any preventative or corrective action taken in relation to the device.  However, this requirement only applies to the lower risk classes of devices.  The PMS report must be produced within 3 years of the device being placed on the market / put into service and updated every 3 years thereafter.
• A periodic safety update report (“PSUR” – regulation 44ZM) is the more demanding alternative to a PMS report and applies to the higher risk classes of devices.  Again, a good deal of detail is set out regarding what must be included in the PSUR, although manufacturers do have the option of grouping devices that have a similar purpose/technology into a single PSUR.  Depending on the risk classification of the device, the PSUR must be updated every 1 or 2 years.
• A “trend report” (regulation 44ZN) must be submitted by a manufacturer to the MHRA if there is any “significant increase” in the frequency or severity of incidents involving the device.  The regulation attempts to define “significant increase” by reference to the statistical methodology set out in the PMS plan, but there is likely to be debate in future about when the trend report requirement is triggered.

Key PMS requirements on manufacturers – serious incidents, corrective action and safety notices

The previous section of this article related to mandatory data and information that must be collated by manufacturers, but the 2023 Regs also set out, in some detail, the steps that manufacturers will need to take in certain circumstances.  These are:

• Preventative or corrective action (regulation 44ZG) that a manufacturer must take if a risk to the safety or performance of the device has been identified, or the device is no longer conforming to the essential requirements.  However, it is left to the judgment of the manufacturer as to when the threshold for such action has been met, and also what is the “necessary” preventative or correction action required.  Once that threshold has been met, there are various notification and monitoring obligations.
• Reporting and investigating serious incidents (regulations 44ZH and 44ZI).  “Serious incidents” are defined as those that have led (or might have led) to a person’s death, to a serious deterioration in a person’s health, or to a serious public health threat.  In such cases, the deadlines for manufacturers to report to the MHRA are understandably very short; 2 days in the case of public health, or 10 days in the case of a person’s death or serious health deterioration.  Manufacturers are required to provide extensive detail in the initial report and must then “as soon as possible” investigate and submit a further report.  MHRA also have powers to take action of their own in relation to the investigation and compel the manufacturer to provide information and documents.
• Field safety corrective action (“FSCA” – regulation 44ZJ) and field safety notices (“FSN” – regulation 44ZK).  FSCA is defined as corrective action taken by a manufacturer regarding the safety of a device already on the market.  As with serious incidents, there are various requirements on what FSCA information must be reported to the MHRA (including FSCA action taken abroad).  FSNs must then be published and manufacturers are to take “all reasonable steps” to alert users of the device.

Key PMS requirements on the MHRA

The MHRA itself is given duties in relation to processing the information it gathers under these PMS provisions, in order to spot trends and identify potential safety issues.  The MHRA can also compel manufacturers to investigate and produce a report, if the MHRA has safety or risk concerns.

Conclusions

The final form of the 2023 Regs may differ once they have been through the WTO process, further refined within UK Government and been through the Parliamentary approval process.  However, these draft 2023 Regs nevertheless provide an interesting insight into the style and format of how the new medical devices regime is likely to look across both the PMS and non-PMS aspects of the new GB regulatory regime. 

The drafting is both fairly detailed in terms of what the various plans and reports must include, but there is also a reasonable amount of discretion afforded to manufacturers in relation to how and when to comply with a number of the requirements.

The content of the draft 2023 Regs closely reflect the PMS requirements under the EU Medical Device Regulation 2017/745 (“EU MDR”) and EU In Vitro Diagnostic Medical Device Regulation 2017/746 (“EU IVDR”) which will make compliance simpler for those manufacturers also operating within the EU MDR/IVDR.  However, PMS documentation will need to be kept for longer in GB than in the EU.

Next steps

How these new obligations will be monitored and regulated by the MHRA once they are in force next year will be the key test for how the new GB regulatory regime compares to its international counterparts.

If you require advice on the current legislative requirements, or how the regulatory regime is currently being amended, in relation to your organisation’s specific product(s), please contact the authors, or the Hogan Lovells’ attorneys with whom you regularly work.