As we have written previously, the UK government recently released a draft copy of a statutory instrument which will introduce new post-market surveillance (PMS) rules for medical devices in Great Britain (UK PMS Regulation). The UK PMS Regulation was released as part of a notification to the World Trade Organisation of new trade-related measures. It is expected that the UK PMS Regulation will enter into law in December 2023 and will apply to medical devices placed on the market in Great Britain from July 2024.
In most respects, the rules which will be introduced into the UK’s Medical Devices Regulations 2002 (UK MDR) by the UK PMS Regulation mirror those found in the EU Medical Device Regulation 2017/745 (EU MDR) and In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR). This is consistent with the minimally divergent approach adopted by the UK government in its response to the consultation on the post-Brexit medical devices regulatory framework for Great Britain.
However, on closer inspection, there are some interesting ways in which the UK PMS Regulation takes a slightly different approach to the EU MDR and IVDR. Manufacturers will need to be alive to these differences as they prepare new UK MDR-compliant PMS plans for devices which will be placed on the market in Great Britain from July 2024.
Retention of PMS-related documentation
Under the EU MDR, a manufacturer of a device must retain the technical documentation relating to that device for a period of 10 years from the date on which the last device is placed on the market in the EU. Where the device is an implantable device, the technical documentation must be retained for a period of 15 years.
‘Technical documentation’ includes documentation relating to PMS, such as the manufacturer’s PMS plan and records of PMS activities, such as incident reports and field safety corrective actions.
Materially identical retention periods apply for devices regulated under the IVDR.
The UK PMS Regulation takes a different approach as each manufacturer will need to retain such PMS-related documentation relating to a medical device for the longer of:
- the ‘lifespan’ of the last device of that device model that is placed on the market or put into service in Great Britain (a novel concept which does not appear in the EU MDR or IVDR); or
- 10 years (or 15 years if the device is an implantable device).
The ‘lifespan of the device’ is defined in the UK PMS Regulation as a period consisting of:
- The shelf life of the device; plus
- The period that the manufacturer expects the device to perform as intended; plus
- The period that it is reasonably foreseeable that the device will remain in use.
Such a period of time will almost always exceed the minimum retention period of 10 (or 15) years prescribed in the UK PMS Regulation. As a result, this will tend be the period for which PMS documentation must be retained for most devices.
As part of preparing a UK-compliant PMS plan for a medical device, a manufacturer will be required to document what it considers to be the lifetime of the device and the lifespan of the device. This will require an evaluation of how the device is actually used under real world conditions – which may need to address instances where end users ignore the shelf life specified by the manufacturer.
Given that many PMS-related documents will contain personal data (including special category personal data), such as user complaints and reports of serious incidents, there is an inherent tension between compliance with the UK PMS Regulation and the data minimisation principle found in UK data protection law. It would be helpful for the MHRA or the Information Commissioner to release some guidance on this point. In the absence of such guidance, each manufacturer will need to get by with a rational and documented rationale for the approach it has adopted.
Reporting of field safety corrective action (FSCA) carried out in other jurisdictions
Under the EU MDR and the IVDR, a manufacturer does not generally need to report a field safety corrective action which is conducted in relation to a device outside of the EU. The only exception to this is where the FSCA is carried out in relation to a device which has also been placed on the market in the EU, and the reason for the FSCA is not limited to the devices which have been placed on the market outside the EU.
In this regard, MDCG guidance gives the example of a recall conducted in relation to certain defective lots of a device. If none of the devices in the affected lots have been placed on the market in the EU, then there is no need to report that recall to a competent authority in the EU.
The UK PMS Regulation takes a much more conservative approach. Under the UK PMS Regulation, where an FSCA is undertaken outside of Great Britain in relation to a medical device which has also been placed on the market in Great Britain, the manufacturer will always need to notify the MHRA. The manufacturer will also need to explain why the reasons for conducting an FSCA in relation to devices outside of Great Britain do not also apply to devices placed on the market inside Great Britain.
The approach adopted in the UK PMS Regulation reflects the position adopted by most notified bodies in their contracts with manufacturers under the EU MDR. As such, while the statutory positions are divergent, this is not likely to impose a significant additional burden on manufacturers in practice.
However, it will be interesting to see how closely the MHRA will scrutinise the decision of a manufacturer to exclude Great Britain from the scope of a FSCA.
PMS for devices under exceptional use authorisation
Broadly speaking, an “exceptional use authorisation” is a discretionary derogation granted by the MHRA under the UK MDR to allow a manufacturer to place on the market a medical device which has not undergone conformity assessment. Such derogations were extensively used during the pandemic to allow essential medical devices to be rapidly brought to market without first undergoing a lengthy conformity assessment.
Competent authorities in the EU have the power to grant comparable derogations under Article 59 of the EU MDR. These are commonly (and unimaginatively) referred to as Article 59 derogations.
Unlike the EU MDR, the UK PMS Regulation confirms that a medical device which is placed on the market in Great Britain under an exceptional use authorisation is not subject to the PMS obligations set out in the UK PMS Regulation.
In practice, it is unlikely that this will represent a genuine difference between the EU MDR and the UK MDR. An exceptional use authorisation under the UK MDR is always granted subject to conditions. Invariably these conditions require the manufacturer to monitor the safety of its device and to report regularly to the MHRA. In other words, the MHRA will almost always require a manufacturer to operate something like a PMS system when it grants an exceptional use authorisation.
PMS for CE Marked devices
One of the features of the UK’s post-Brexit medical device regulatory framework is that it has continued to unilaterally recognise CE Marks affixed to medical devices following completion of a conformity assessment under EU MDR. It has not yet become mandatory to conduct a conformity assessment under the UK MDR prior to placing on the market a medical device in Great Britain.
The UK PMS Regulation recognises that this will remain the case for some time.
As in the EU MDR, the UK PMS Regulation requires a manufacturer to continuously update the processes and documentation associated with its device in response to data gathered through its UK PMS system. Such processes and documentation include:
- the instructions for use;
- device labelling;
- the evaluation of clinical data concerning the device showing its compliance with the essential safety and performance requirements; and
- the technical documentation.
However, the UK PMS Regulation also states that a manufacturer does not need to use data from its UK PMS system to update such processes and documentation where the device has been placed on the market under a CE Mark. This makes sense.
Given that there will be subtle differences between a UK PMS system and an EU PMS system, there may be instances where the requirements of these systems will conflict and it would be impossible for the manufacturer to comply with both. In this case, where a device has been CE Marked under the EU MDR, the manufacturer ought to comply primarily with its EU PMS system. This system will have been reviewed by a Notified Body and will form part of the basis for the device having successfully completed conformity assessment.
This does not mean that a UK PMS system is simply irrelevant to a device which has been CE Marked. The operation of such a system will still be mandatory where a CE Marked device is placed on the market in Great Britain. A manufacturer will also have to consider data which is gathered through its UK PMS system in accordance with its EU PMS system, in the same way that it would have to consider data arising from a device placed on the market in any other third country. The UK PMS Regulation only establishes that the EU PMS system will take priority for a CE Marked device when it comes to updating documentation and processes.
More detailed provisions
As well as the more substantive differences between the UK PMS Regulation and the EU MDR PMS requirements explained above, there are also some small technical differences which manufacturers should review when preparing a PMS plan for Great Britain:
- the UK PMS Regulation contains a more detailed (and potentially slightly more expansive) definition of an ‘incident’;
- the UK PMS Regulation requires that corrective and preventive actions which are undertaken as a result of PMS must always be notified to the manufacturer’s UK Responsible Person and UK Approved Body (if applicable);
- the UK PMS Regulation is more prescriptive than the EU MDR as regards the periods for preparing and refreshing Post-Market Surveillance Reports and Periodic Safety Update Reports; and
- the UK PMS Regulation appears to set a slightly lower threshold for triggering trend reporting to the MHRA.
While manufacturers can certainly use their existing EU MDR PMS plans as a starting point for preparing a PMS plan which complies with the UK PMS Regulation, they should be sure to take into account the fine-textured differences which are developing between the UK and EU regulatory frameworks.
 MDCG 2023-3 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices