New Post-Market Surveillance Requirements for Medical Devices UK in 2025

UK medical device regulations have undergone a significant update. From June 16th, 2025, new Post-Market Surveillance (PMS) requirements came into effect, aiming to monitor medical device safety more effectively. This reform enhances patient protection and ensures faster responses to incidents.

These enhanced medical device regulations apply to all UKCA- and CE-marked devices on the Great Britain market after this date. Manufacturers must now establish updated post-market surveillance for medical device systems, adhere to stricter reporting timelines, and provide risk-proportionate safety reports. This represents a crucial shift towards a more rigorous, data-driven regulatory environment, with the MHRA medical device reporting system at its core. Adaptation to these changes is essential for maintaining ongoing compliance and capitalising on future market opportunities for any new medical device.

Effective as of June 16th, 2025, the updated UK medical devices regulations introduced significant changes to Post-Market Surveillance (PMS). These new medical device regulations aim to improve patient safety and streamline oversight, including:

• Mandatory PMS Plans: Comprehensive, risk-based plans are now required.
• Faster Incident Reporting: MHRA medical device reporting timelines are significantly shortened (e.g., 2 days for public health threats and 10 days for death/serious deterioration).
• Enhanced Safety Actions: Stricter requirements for Field Safety Corrective Actions (FSCAs) and Field Safety Notices (FSNs), including mandatory MHRA pre-circulation review.
• Periodic Safety Reporting: Differentiated by risk, higher-risk new medical device types require more frequent PSURs, while lower-risk devices need PMSRs.
• Expanded Data Collection: Greater emphasis on real-world safety and performance data.
• Increased UKRP Duties: Non-UK manufacturers’ UK Responsible Persons (UKRPs) have expanded compliance responsibilities.

These changes establish a more proactive, rigorous, and data-driven post-market surveillance medical device regime across the UK.

Related Reading: Demystifying UK Medical Device Regulation: A Beginner’s Guide

The core objective of the new PMS medical device regulations is to significantly enhance patient safety. Manufacturers must actively monitor medical device performance post-market, enabling quicker identification and response to safety issues. These changes, a direct result of the IMMDS Review, ensure high standards for new medical devices throughout their lifecycle.

Beyond immediate safety, these post-market surveillance rules prepare for future UK medical device regulations, including international recognition routes for faster market access. The MHRA’s approach balances safety with MedTech innovation. Compliance with these PMS requirements secures ongoing adherence and offers a strategic advantage.

Post-Market Surveillance for medical devices is a continuous, systematic process of monitoring device performance, safety, and effectiveness once on the market. It involves actively collecting, analysing, and interpreting real-world data. Key objectives include ensuring ongoing compliance, detecting adverse effects, identifying product improvements, and maintaining trust in medical devices.

The new UK medical device regulations emphasise proactive vigilance. Beyond traditional reactive elements like complaint handling, the updated framework stresses systematic monitoring of product performance in everyday use, scientific literature review, and post-market clinical/performance follow-ups (PMCF/PMPF). 

Manufacturers are now expected to actively identify potential issues and continuously optimise device performance based on real-world data, integrating this into core operations. This approach strengthens post-market surveillance practices for medical devices.

Related Reading: The Complete Guide to Clinical Evaluation for Medical Device Market Access

The new PMS regulations have a broad scope, applying to all medical devices placed on the Great Britain market after this date. This includes:

• All Medical Device Classes: Class I, IIa, IIb, III, and active implantable medical devices.
• In Vitro Diagnostic Devices (IVDs)
• Software as a Medical Device (SaMD).

Crucially, the updated medical device regulations apply to UKCA-marked and CE-marked devices. This means that even CE-marked devices must comply if placed on the GB market after the effective date.

For international manufacturers, this creates a significant dual compliance requirement. Relying solely on EU MDR compliance is insufficient for medical devices in the UK. Manufacturers must establish distinct UK-specific PMS processes, documentation, and reporting mechanisms. This ensures the MHRA maintains full oversight of device safety and performance, regardless of the initial market access pathway, especially for a new medical device.

While the new Post-Market Surveillance regulations are broad, certain medical devices are subject to specific exemptions or tailored requirements.

Exempted or Partially Exempt Devices:

• Devices used for clinical investigations.
• In vitro diagnostic devices (IVDs) under performance evaluation.
• Devices approved for exceptional use (e.g., humanitarian or military purposes).
• Custom-made devices are partially exempt from some PMS requirements (e.g., PMSR or PSUR obligations), but adverse trends must still be identified and addressed.

A key principle of the new framework is a risk-proportionate approach. This means the intensity and specific requirements for PMS activities vary based on the device’s inherent risk level to patients. This approach by the MHRA aims to optimise regulatory resources, focusing efforts on areas with the highest potential for patient harm. 

Manufacturers must conduct accurate risk classification of their medical devices to determine and precisely implement their specific PMS obligations.

Related Reading: The Essential Guide to UK and EU Medical Device Post-Market Surveillance for 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) is the central authority for medical devices in the UK, ensuring all devices on the market are effective and acceptably safe.

Key functions under the new PMS regulations include:

• Guidance and Support: The MHRA actively supports manufacturers in adapting to new Post-Market Surveillance regulations by publishing comprehensive guidance.
• Reporting Platform (MORE): The Manufacturers Online Reporting Environment (MORE) portal is the exclusive platform for submitting serious incident, trend, and Field Safety Corrective Action (FSCA) reports for devices in Great Britain or Northern Ireland.
• FSN Review: The MHRA critically reviews proposed Field Safety Notices (FSNs) before their dissemination.

Manufacturers should view the MHRA as a key partner in patient safety, not just an enforcement body. Active engagement with MHRA medical device reporting guidelines and diligent use of the MORE portal are crucial.

Managing the MHRA’s requirements, especially with accelerated reporting timelines, can be complex. Russell Regulatory Consultants offers expert guidance to ensure your MHRA medical device reporting and regulatory interactions are friction-free, helping you maintain compliance and adapt to the evolving UK regulations for new medical devices.

Related Reading: A Step-by-Step Overview of MHRA Registration for Your Medical Device

The new PMS regulations significantly increase the responsibilities of manufacturers and UK Responsible Persons (UKRPs) regarding medical devices.

• Establish Robust PMS Systems: Proactively monitor device performance, safety, and effectiveness.
• Data Collection and Reporting: Continuously gather safety data, report incidents, and mitigate risks throughout the product lifecycle.
• Swift Action: Be prepared to take immediate corrective and preventive actions when issues arise.

For non-UK manufacturers, appointing a UKRP is mandatory. Their duties are now critically expanded:

• Document Management: Request and securely store UK-compliant PMS plans and Periodic Safety Update Reports (PSURs).
• Rapid Submission to MHRA: Submit these documents to the MHRA within a strict three-day timeframe if requested.
• Compliance Oversight: Actively monitor manufacturer compliance and escalate issues as per contractual agreements.

With UKRPs becoming critical compliance gatekeepers, non-UK manufacturers must ensure their appointed UKRPs are capable and integrated to meet stringent UK medical device regulations. Re-evaluating existing agreements and deeper integration into post-market surveillance for medical devices and quality systems is often necessary.

Russell Regulatory Consultants provides comprehensive UKRP services, bridging this compliance gap for new and existing medical devices. We manage your PMS plans, PSURs, and MHRA medical device reporting, ensuring compliance with the updated UK medical device regulations.

Related Reading: Understanding the Role and Responsibilities of the UK Responsible Person

The new UK medical device regulations make drafting a Post-Market Surveillance plan mandatory for all medical device manufacturers. This plan’s scope and intensity must be proportionate to the device’s risk profile. This shift requires a structured, documented approach to post-market activities, moving away from reactive measures.

Minimum content for the PMS plan includes:

• Explicit objectives of the PMS system.
• Processes for real-world data gathering and analysis.
• Mechanisms for fulfilling Great Britain’s vigilance reporting obligations.
• Links to preventive and corrective actions, integrated with risk management.

Manufacturers must continuously gather performance and safety information throughout the device’s anticipated lifetime.

The new UK medical device regulations heavily emphasise the active collection and assessment of real-world safety and performance data. Your post-market surveillance system must gather and analyse feedback from all user groups (patients, professionals, public) on usability.

Data collection needs to be thorough, covering your device’s performance across all markets and including insights from competitors’ medical devices. This holistic approach to post-market surveillance for medical devices requires advanced data mechanisms, providing both compliance assurance and competitive intelligence under the new medical device regulations.

The updated UK medical device regulations mandate strong integration of post-market surveillance with a manufacturer’s risk management. PMS data must directly inform risk analysis and technical documentation, ensuring continuous risk evaluation and timely corrective actions for medical devices (often following ISO 14971). This creates a vital closed-loop system for ongoing improvement, making PMS a dynamic part of the device’s lifecycle that continuously refines its risk profile.

Demonstrating medical device regulations compliance requires stringent documentation. All PMS records must be retained for the device’s full PMS period (minimum 15 years for implantables, 10 for others).

Manufacturers must regularly document PMS activities in a PMSR or PSUR (based on risk). Non-UK manufacturers’ UKRPs must store these UK-compliant documents and submit them to the MHRA medical device reporting system if requested.

Tight deadlines require rugged, secure, and easily accessible digital systems for all medical devices, including any new medical device, ensuring audit readiness.

The new UK medical device regulations introduce a more rigorous framework for serious incident reporting and proactive trend analysis.

Serious incidents (leading or potentially leading to death, serious health deterioration, or public health threats) must be reported. This includes use errors posing a risk of serious harm.

Revised Timelines for MHRA Medical Device Reporting:

• Public health threat: 2 calendar days.
• Death or unanticipated serious deterioration: 10 calendar days.
• All other serious incidents: 15 calendar days (down from 30).
• Do not delay reporting due to incomplete information.

All serious incident, trend, and Field Safety Corrective Action (FSCA) reports for Great Britain or Northern Ireland must be submitted exclusively via the MHRA’s MORE portal. 

If a manufacturer identifies a market problem with a medical device that could cause serious harm, an FSCA is required. This often involves recalls or modifications affecting devices outside direct control.

• MHRA Review of FSNs: Proposed Field Safety Notices (FSNs) must now be submitted to the MHRA for review before customer circulation. Urgent patient safety actions are exceptions. FSNs must be searchable, include UDI (unique device identifiers), reflect risk, and be broadly disseminated.
• Reporting FSCAs Outside GB: If an FSCA is performed outside Great Britain for similar devices supplied in GB (but not directly affected), the MHRA must be notified within three UK working days of FSN circulation.

The updated PMS regulations mandate systemic post-market surveillance through consolidated and trend reporting.

• Consolidated Reporting (PSRs): Manufacturers can request MHRA permission for consolidated reporting of similar serious incidents via Periodic Summary Reports (PSRs), especially after an FSCA or when the root cause is known.
• Identifying and Reporting Adverse Trends: Manufacturers must have systems to detect significant increases in the number or severity of serious or non-serious incidents against pre-determined thresholds. This demands sophisticated data analytics to identify systemic issues before they escalate, benefiting any new medical device.

The MHRA wields significant authority to ensure medical devices meet safety and performance standards. New Post-Market Surveillance regulations equip them with more real-world safety data, enabling swift action to reduce or avoid harm.

The MHRA’s broad enforcement powers include inspections, documentation requests, warning letters, and investigations. This signals an enforcement stance that demands continuous compliance from manufacturers.

Failing to comply with the new UK medical device regulations carries severe consequences:

• Loss of Market Access: Manufacturers may be prohibited from placing or keeping their medical devices on the Great Britain market.
• Regulatory Penalties: Enforcement actions and potential legal ramifications.
• Commercial Disruption: Product withdrawals and significant financial impact.
• Reputational Damage: Erosion of trust among patients, healthcare providers, and the public.

These risks turn PMS adherence from a mere legal obligation to a critical commercial imperative for a new medical device.

To manage the new post-market surveillance regulations, manufacturers should adopt an integrated approach:

• Engage with MHRA Guidance: Immediately align systems, documentation, and reporting structures with MHRA guidelines, ensuring audit-ready PMS documentation.
• Strategic UKRP Collaboration: Non-UK manufacturers must closely collaborate with their UK Responsible Persons (UKRPs), using their expanded role.
• Rugged Surveillance Systems: Implement systems capable of comprehensive medical device performance and safety data capture, including real-world feedback.
• Continuous Assessment: Regularly assess medical device performance to identify issues.

Effective compliance requires a cultural shift, integrating PMS into every product lifecycle stage, encouraging collaboration, continuous training, and data-driven decision-making. Viewing these changes as an opportunity enhances overall quality management, transforming compliance into a strategic advantage for patient safety and market presence.

Related Reading: The Importance of Quality Management Systems for UK Medical Devices

New UK medical device regulations for Post-Market Surveillance were effective as of  June 16th, 2025. Proactive compliance is critical for market access and patient safety for every new medical device.

Struggling with post-market surveillance medical device complexities or tight MHRA medical device reporting timelines? Russell Regulatory Consultants offers specialised expertise in UK medical device regulations. We provide tailored solutions to simplify these processes, ensuring your products meet the highest standards and boost market standing.

Partner with us to transform regulatory challenges into a competitive advantage. Our expert guidance ensures post-market surveillance and ongoing compliance. Focus on innovation and growth with your medical device compliance expertly managed.

Ready to confidently manage the 2025 changes? Schedule a free call with Russell Regulatory Consultants today to discuss how we can secure your market success.

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