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Published 17 August 2023
As part of the UK government's ongoing reform of medical device regulation in the UK, a draft statutory instrument has been published to amend the existing post-market surveillance regulations in Great Britain. While details of the wider future regulatory system for medical devices are still awaited, the government prioritised tightening the post-market surveillance regime because of the importance it placed on improving patient safety.
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 and can be found here. 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.
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.
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