The UK’s medical device and in-vitro diagnostic device regulation is undergoing significant changes to enhance post-market surveillance (PMS) requirements. The MHRA (Medicines and Healthcare Products Regulatory Agency) conducted a consultation, which received responses supporting the need for more transparent and risk-proportionate PMS requirements. Consequently, the UK MDR 2002 (SI 2002 No 618, as amended) will be amended through the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023, aiming to create consistency for manufacturers and improve adverse incident data reporting.

Key Highlights for Medical Device Manufacturers

1. Clarified PMS Period: The PMS period starts from the day the first device of a model is put into service or placed on the market and ends with the last device’s end of life for that model. During this period, manufacturers must fulfill all PMS obligations, including creating a comprehensive PMS plan and submitting PSURs (Periodic Safety Update Reports) based on risk class.
2. MORE Portal Enhancements: The MHRA is enhancing the MORE portal, dedicated to adverse incidents and vigilance reporting, to ensure better user experience and reporting efficiency. The portal will be fully effective from August 31, 2023.
3. Post-Market Surveillance System (Regulation 44ZE): The UK mandates establishing a PMS system for each medical device, proportionate to its associated risks. The system should continuously analyze quality, performance, and safety data throughout the device’s lifespan.
4. Post-Market Surveillance Plan (Regulation 44ZF): The PMS plan forms the basis of the PMS system and must be clear, organized, and searchable. It outlines processes for data collection, analysis, and interactions with relevant parties.
5. Preventive and Corrective Actions (Regulation 44ZG): Manufacturers must immediately reduce risks or non-conformities that compromise a device’s safety or performance. Notifications about field safety corrective actions are required.
6. Reporting Serious Incidents (Regulation 44ZH): Manufacturers must promptly report serious incidents involving their devices to the Secretary of State, including detailed information about the incident and any preventive or corrective actions taken.
7. Field Safety Corrective Actions and Notices (Regulation 44ZJ): Manufacturers must conduct a risk assessment and notify the Secretary of State before implementing any field safety corrective actions. A Field Safety Notice must accompany the action.
8. Post-Market Surveillance and Periodic Safety Reports (Regulations 44ZL and 44ZM): Manufacturers are required to produce Post-Market Surveillance Reports (PMSRs) or Periodic Safety Update Reports (PSURs) for certain devices, summarizing surveillance data and actions taken.
9. Trend Reporting (Regulation 44ZN): Significant increases in the frequency or severity of incidents must be reported to the Secretary of State to investigate potential safety issues.

Post Market Surveillance in UK Medical Device Regulatory Framework

Post-market surveillance plays a critical role in the UK’s medical device regulatory framework. Manufacturers must prioritize establishing a comprehensive PMS system, developing clear and organized PMS plans, and promptly reporting incidents and corrective actions. Adhering to these regulations ensures their medical devices’ ongoing safety and reliability throughout their lifecycle, contributing to a safer healthcare system for both patients and healthcare professionals. These regulatory changes aim to strengthen oversight for medical devices and in-vitro diagnostic devices in the UK, emphasizing improved post-market surveillance and vigilance to safeguard public health and enhance patient safety.

Digital Systems to support Post-Market Surveillance in the UK

In the journey to meet post-market surveillance obligations, digital systems offer invaluable support to medical device and IVD manufacturers. Utilizing advanced solutions, manufacturers can effortlessly manage the entire PMS process, ensuring timely reporting and adherence to regulatory timelines. By leveraging these systems, manufacturers can navigate the regulatory landscape more efficiently and effectively and embrace a proactive approach to compliance while contributing to maintaining a trustworthy and responsible presence in the medical device market.

Reference:

1. https://members.wto.org/crnattachments/2023/TBT/GBR/23_11298_00_e.pdf
2. https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
3. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1154632/

MedTech Intelligence Content Partner

This blog post was previously posted by Celegence LLC. The author is employed by or otherwise directly associated with this Partner.