Updated post-market surveillance (PMS) rules for medical devices in the UK: differences from the EU regulations

In-depth analysis

The UK Government has published a draft statutory instrument on the World Health Organisation website to amend the Medical Devices Regulations 2022 (the UK MDR). This draft legislation seeks to insert new post-market surveillance (PMS) requirements for medical devices placed on the market in Great Britain (GB). This is subject to 60 days of consultation from 26 July 2023. If passed by Parliament, it is expected that this legislation will come into force in mid-2024.

The publishing of this draft statutory instrument follows the consultation on the future regulation of medical devices in the UK and is part of the wider revamp of the UK's medical device regulatory framework following Brexit. Medical devices placed on the market in Northern Ireland will continue to be subject to the EU regulatory framework under the Northern Ireland Protocol.

The requirements in the proposed PMS regulations closely resemble those already established in the EU Medical Device Regulation 2017/745 (the EU MDR) and the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (the EU IVDR). However, there are differences, some of which are subtle, and some significant, but which nevertheless mean that the requirements will not be the same in GB as in the EU. Therefore, if the draft legislation becomes law in this form, manufacturers across Europe should check their planned PMS activities specifically against the UK legislation and not automatically assume that they are the same as in the EU.

Naturally, reports for devices placed on the market or put into service in GB must be submitted to the MHRA and in some cases to the UK approved body and UK responsible person (UKRP), if any. If the MHRA is separately notified of incidents and informs the manufacturer of the complaints, the manufacturer must determine if it is a "serious incident" and if so, must take action accordingly and if not, explain why. Similarly, if the MHRA notifies a manufacturer of an identified risk or safety concern, then the manufacturer is obliged to investigate and report back to the MHRA on its conclusion and provide any corrective and preventative action (CAPA).

Same as EU regulations

There are some PMS aspects which are the same as the EU. These include the requirement to maintain a PMS system based on the PMS plan for each device placed on the market. As in the EU, this system is to be used to identify preventive and corrective actions. However, the UK has chosen to include many subtle differences which will require careful analysis when compared with an EU PMS strategy to ensure that the UK regulations are respected for devices placed on the market or put into service in GB.

Different from EU regulations

Different definitions

The GB definition of "preventive action" is potentially broader and includes action to "reduce a risk posed by a device", which does not require that any "non-conformity" has occurred, although this could be similar to any "other undesirable situation". Manufacturers would be wise to consider the EU and the GB definitions separately in relation to a specific issue to determine whether different action is required in each region.

The GB definition of "incident" is similar to the EU regulations, but includes some additions, capturing more potential failures. This includes a "side-effect" (not defined) with a negative impact on health of an individual, patient management or even public health. Furthermore, for diagnostic products an "incident" includes an "erroneous result". Unlike in the EU regulations, this does not require harm arising from a consequential decision. It also does not take account of the fact that the erroneous result might be within the permitted tolerance for the diagnostic device. Consequently, more events will be captured by the GB definition of "incident".

The GB definition of "serious incident" includes the same terminology as the EU regulations, but then extends it to include a definition of "serious deterioration of any person's state of health" which are defined as: hospitalisation or prolongation of hospitalisation, medical treatment, chronic disease, and foetal distress or foetal death. This potentially expands the types of serious incidents captured by the definition.

Different requirements

Reporting and investigation of serious incidents: the reporting requirements match the EU ones, except on a few points:

UK law specifies the information to include in the report, so manufacturers should check this list before reporting serious incidents in GB.

Perhaps obviously, the final report must be submitted to the MHRA via the MORE portal.

The exception of expected and documented side-effects does not appear in the UK legislation. These must therefore be reported in GB where they might not be in the EU.

Preventive and corrective actions: manufacturers should of course note the potentially broader definition of "preventive action", and that the notification is to the UKRP or approved body (if either exist) and the MHRA. The provisions are otherwise in parallel with the EU regulations.

Post-market surveillance report (PMSR): the requirements are the same as EU regulations, save that:

Classification is determined based on the legislation under which the device is placed on the market (MDD/MDR or UK regulations). Under those a PMSR is required for Class I general medical devices, or class A and B of the IVDR, or which are not listed in Annex II of the IVDD.

There is greater clarity on timings, in that the PMSR must be: (i) produced within three years of the device being placed on the GB market or put into service, whichever is sooner; and (ii) updated every three years until the last device on the market is reasonably foreseeably no longer in use. The duration of the requirement is not specified in EU regulations.

Periodic Safety Update Report (PSUR): the requirements are applied to devices that do not require a post-market surveillance report under UK law, which is a different approach than under the EU regulations. Consequently manufacturers will need to verify whether a PSUR is required in GB and should not make the determination based on the EU regulations.

Of particular note are the different intervals for production of a PSUR. In the UK this is within two years of the device being placed on the market or put into service in the UK, and thereafter at least every two years for class IIa general medical devices, according to the laws under which they are placed on the UK market. This means that manufactures of all other general medical devices and all IVDs required to produce a PSUR must do so within the first year of placing on the UK market and annually thereafter. The EU IVDR only requires annual PSURs for class C and D IVD devices.

The requirement applies to each device or category or group of devices and not, as in the EU regulation, for each device and categories or groups of devices. Categories are determined by either: (i) if the devices are covered by the same clinical evaluation report under EU regulation; or (ii) if the devices have the same or a similar intended purpose and are based on the same or similar technology and the manufacturer considers that the similarity between the devices justifies a single PSUR.

The content of the PSUR will be different in GB, as it additionally includes: (i) a description of any preventive or corrective action and the rationale for doing so; and (ii) the conclusions of any post-market clinical follow-up required. Obviously, sales volumes are those for the UK, but additional information required includes a description of the characteristics of the population using the devices, with estimates for numbers using the device in the UK and outside the UK, as well as how often they use the device.

Each PSUR must be submitted to the approved body (if there is one) for review if the device is: (i) class III; (ii) implantable (including active implantable); or (iii) listed in Annex II of the in vitro diagnostic directive 98/79 (IVDD). The approved body must then issue a report to the manufacturer and any UKRP setting out its conclusions.

Field safety corrective actions and field safety notices: the requirements are mostly the same as for the EU, save that the manufacturer must publish the field safety notice on the manufacturer's website and take all reasonable steps to ensure the field safety notice is sent to all known device users, rather than entering it onto a centralised system. The field safety notice must also set out the details of the UKRP.

Trend reporting: these requirements are similar to the EU regulations, albeit with slightly different language, and a detailed list of information to submit. The manufacturer must make these reports to the MHRA via the MORE portal. It is advisable for manufacturers to check the GB list of information before submitting a trend report. The manufacturer is required to respond to MHRA requests with respect to any investigation of the trends within three working days.

Retention of PMS documentation: the manufacturer and the UKRP (if there is one) must retain documentation until the later of: (i) the date the last device is placed on the UK market is no longer in use; or (ii) 15 years in the case of an implantable device, or ten years in the case of any other device. This is different from the EU regulations for which the requirement is "10/15 years after the last device has been placed on the market", which could be an error in the UK draft. If not an error, this makes the 10/15 years an absolute number and the period of use the more definitive figure for devices with greater longevity. For devices with an expected lifespan beyond the 10/15 years (as applicable), the retention period will therefore be longer in GB. Manufacturers of these devices will have to consider what this period is and justify it in their PMS systems for GB.

What this means for manufacturers

If this draft legislation becomes law, manufacturers must prepare to take on stricter PMS obligations than those currently in place from June 2024 for medical devices on the market in GB. This will involve amending any current PMS systems, developing PMS plans, and having procedures in place to promptly report and act on incidents, corrective actions and trends in accordance with the new GB requirements. Any PMS policies procedures already developed to handle the EU MDR or IVDR will need to be reviewed in light of the new GB law. Amendments are likely to be necessary to meet the differing GB requirements to ensure future compliance for devices placed on the market or put into service in GB.