UK’s Strengthened Post-Market Surveillance Requirements for Medical Devices

The UK Medicines and Healthcare products regulatory Agency (MHRA) published a draft of ‘The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023’ (UK PMS Regulations) which will amend the current UK Medical Devices Regulations 2002 (UK MDR) to introduce more comprehensive post market-surveillance (PMS) requirements for medical devices placed on the market in Great Britain (England, Wales and Scotland).

Currently, PMS requirements for medical devices placed in Northern Ireland are contained within the EU Medical Devices Regulation (2017/745) (EU MDR) and the EU In Vitro Diagnostic Medical Devices Regulation (2017/746) (EU IVDR) under the terms of the Northern Ireland Protocol upon Brexit.

The proposed UK PMS Regulations intend to significantly bolster the PMS requirements in Great Britain by mirroring the PMS rules set out in the EU's medical devices regime (EU MDR and IVDR) which the UK has not adopted post-Brexit.

Consequently, the UK PMS Regulations aim to introduce more explicit and substantive PMS requirements for the manufacturers to ensure transparent and efficient vigilance processes are in place and improve the quality of PMS activities which shall safeguard public and patient safety. The UK PMS Regulations may be adopted in December 2023 and come into force in June 2024.

Purpose

As it stands, the UK MDR sets out a general principle of PMS obligations complemented by the MHRA’s supporting guidance that addresses actual practical PMS activities such as incident reporting and field safety corrective actions. The UK PMS Regulations will add a new Part 4A (“Post-market surveillance requirements”) in the UK MDR to replace the existing PMS requirements in Schedule 2A. This is to ensure that detailed PMS requirements are substantively incorporated as legislation.

Key PMS requirements

1. PMS System

• Be appropriate to the type of the device and proportionate to its risk.
• Include analysis of data relevant to the quality, performance and safety of the device throughout its lifespan.
• Identify preventive and corrective actions and trends in incidents.

2. PMS Plan

• Specify the ‘lifetime’ and ‘lifespan’ of the device, as defined in the current draft of the UK PMS Regulations.
• Include processes for the collection and assessment of serious incidents and feedback and complaints provided by users and suppliers.
• Investigate complaints and manage incidents and trends.

3. Reporting of Serious Incidents

• Submit a report to the MHRA concerning the serious incident no later than 15 days after becoming aware of the incident.
• Investigate the incident and conduct a risk analysis with a final report.

4. Field Safety Corrective Actions and Notices

• Conduct a risk assessment and submit a report to the MHRA before taking any field safety corrective action.
• Issue a field safety notice to all known users when taking a field safety corrective action.

5. Periodic Safety Update Report (PSUR)

• Produce the first PSUR within one or two years of the device being placed on the market or put into service, whichever is sooner subject to classification of the device.
• Update the PSUR at least every year or two years subject to classification of the device.

6. Retention of PMS Documentation

• Retain PMS documentation during the PMS period of the device model, or 15 years for implantable devices or 10 years for other devices, whichever is longer.

Actions for medical device manufacturers and UK responsible persons

If the proposed changes remain in their current form through the legislative process, the PMS obligations of medical device manufacturers and UK responsible persons will change significantly.

Medical device manufacturers and UK responsible persons can prepare in advance for the UK PMS Regulations by ensuring that relevant stakeholders become familiar with the new requirements. They may also consider taking the following steps to identify any changes that should be made to the current PMS processes:

• Ensure and maintain a PMS system for each device that is placed on the market or put into service
• Identify any deficiencies in the current PMS and quality management procedure against the UK PMS Regulations
• Establish a structured process of monitoring the safety and performance of the device, in particular related to traceability (e.g., information of distributors and end-users)
• Build a standard operating procedure of incident reporting (e.g., appointment of a responsible department or person with a reporting protocol)
• Review and update the current Field Safety Notice template in accordance with the required content of UK PMS Regulations
• Ensure a secured system is in place for retaining PMS documentation and supporting records (e.g., IT and data repository).
• Track periodic reporting of PSUR and the dates of devices being placed on the market

Looking ahead

The draft will now proceed through the regular legislative process. It was notified to the World Trade Organization (WTO) on 26 July 2023 and made available here following the WTO’s Technical Barriers to Trade (TBT) agreement which requires a WTO member country to notify other member countries of any proposed technical regulation, standard or conformity assessment procedure to prevent any technical barriers to trade that may be created between member countries.