The government has published The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023 to amend the current regulations on post-market surveillance of medical devices placed on the market in Great Britain (“PMS Regulations“). The draft statutory instrument was notified to the World Trade Organization and made available on their website on 26 July 2023. The intention is that it will be laid before Parliament in winter 2023 and that it will apply from mid-2024, alongside new guidance.
When a medical device is placed on the UK market, the manufacturer is required under the Medical Devices Regulations 2002 (“UK MDR“) to monitor continually the performance of that medical device and report safety incidents to the Medicines and Healthcare products Regulatory Agency (“MHRA“), the UK’s regulator of medical devices. This post-market surveillance aims to ensure that medical devices continue to be safe, perform well and that appropriate action is taken in the event of adverse incidents.
The PMS Regulations will apply to medical devices placed in Great Britain, whether they have a CE or UKCA mark, while Northern Ireland remains subject to EU medical device regulation. Devices for clinical investigation or performance evaluation are not included in the new PMS Regulations. The PMS Regulations seek to improve the identification of issues and the ability for manufacturers and the government to take appropriate action to protect patients.
We have summarised below key obligations that manufacturers should familiarise themselves with.
- Post-market surveillance plan: The PMS Regulations detail what the post-market surveillance plan should address and include, such as the manufacturer’s processes for collecting, processing and assessing data and its processes to investigate complaints and manage incidents and trends. The plan is intended to encourage the use of more rigorous scientific methods to identify potential medical device safety issues. Manufacturers are required to provide the plan to the MHRA within three working days of a request.
- Maintenance of a post-market surveillance system: A post-market surveillance system is required for each medical device placed on the market or put into service, based on the post-market surveillance plan. The system must be (1) proportionate to the risk posed by the device; (2) appropriate to the type of medical device; and (3) include analysis of data relevant to the quality, performance and safety of the medical device through its lifespan and a record of the manufacturer’s conclusions based on that analysis. This system must be used to identify preventive actions and corrective actions, trends in incidents, options to improve the usability, performance and safety of the device and any impact on the post-market surveillance of other medical devices.
- Reporting of serious incidents and field safety corrective actions: Currently, most requirements for the reporting of serious incidents and field safety corrective actions are found in guidance issued by the MHRA rather than in the UK MDR. The PMS Regulations include enhanced reporting requirements for serious incidents and field safety corrective actions and set out applicable timescales.
- Initial reporting of serious incidents
- (1) The manufacturer must report to the Secretary of State any serious incident involving the manufacturer’s device.
- (2) The report must include—
- (a) the manufacturer’s name and contact details;
- (b) the UK responsible person’s name and contact details (if there is one);
- (c) details of the initial reporter of the incident;
- (d) a description of the device, including its current location and any unique device identifiers;
- (e) a description of the incident;
- (f) the manufacturer’s preliminary conclusions in relation to the cause of the incident;
- (g) consideration of whether any field safety corrective action is required to prevent or reduce the risk of a further serious incident;
- (h) details of any preventive or corrective action taken;
- (i) details of similar incidents in relation to similar devices on the market.
- (3) The manufacturer must submit the report—
- immediately after the manufacturer has established the causal (or reasonably possible causal) relationship between the device and the serious incident, and no later than 15 days after the manufacturer becomes aware of the incident.
- If the serious incident being reported involves a serious public health threat, the report must be submitted no later than 2 days after the manufacturer becomes aware of the threat.
- If there is a death or an unanticipated serious deterioration in a person’s state of health, the report must be submitted no later than 10 days after the manufacturer becomes aware of the incident.
- Periodic reporting: The PMS Regulations include more stringent requirements on manufacturers to conduct periodic reviews of their post-market surveillance data, including on the reporting of results and conclusions of analyses of information collected as a result of the post-market surveillance plan. The frequency of the reporting obligations depends on the classification of medical device.
- Retention of post-market surveillance documentation: Documentation must be retained for the longer of (1) the specific period that applies to the relevant medical device model; and (2) 15 years in the case of implantable devices or 10 years in the case of any other medical device.
The PMS Regulations largely align with EU medical device regulation, namely the Medical Device Regulations (2017/745) (“EU MDR”) and the In Vitro Diagnostic Medical Device Regulations (2017/746) (“EU IVDR”) although document retention requirements are extended under the PMS Regulations and there are some new definitions and requirements to note, including for patient engagement. The alignment to the EU MDR and IVDR should make the task of preparation easier for manufacturers who place medical devices on the EU market as they should already have similar systems in place. Others will need to ensure that the necessary systems, plans and documentation are ready by mid-2024.
The MHRA has also updated its guidance document on post-market medical device vigilance procedures. This includes information about the registration process for the new Manufacturer’s On-line Reporting Environment (MORE) portal. Further guidance from the MHRA on the PMS Regulations is promised.
The government has promised a proportionate and phased approach to the implementation of the future regulatory framework, which supports system readiness and minimises the risk of supply disruption for UK patients. It has already put in place legislation that amends the UK MDR to extend the acceptance of CE marked medical devices on the Great Britain market beyond the original cut-off date of 30 June 2023. The PMS Regulations are the second step in the series of statutory instruments that are planned as the government works towards the future regime for medical devices following the UK’s exit from the European Union.
The third and final step will be the future regulations to overhaul the current regulatory framework for medical devices in line with the MHRA’s approach as outlined in the 2021 consultation. The core aspects of this future regime are set to apply from 1 July 2025.
While details of this last phase of reform are awaited, manufacturers can make sure they are ready for the implementation of these strengthened post-market surveillance requirements. While more may be expected in terms of ensuring the ongoing safety of their devices, the close alignment with the EU regime brings a welcome degree of stability for the industry. This in turn helps with the aim of maintaining the UK’s place as a strong competitor in the medical devices sector.
Reference: https://members.wto.org/crnattachments/2023/TBT/GBR/23_11298_00_e.pdf
Leave a Reply