UK MHRA Guidances: Ensuring Medical Device Safety in Great Britain: Field Safety Notices, Post-Market Surveillance, and Custom-Made Devices
- Sharan Murugan
- 16 hours ago
- 3 min read
In recent years, the MHRA has issued several key guidance documents strengthening the lifecycle safety and regulatory oversight of medical devices across Great Britain. Collectively, field safety notices (FSNs), post-market surveillance (PMS) requirements, and custom-made device regulations form an interconnected framework supporting patient safety, regulatory compliance, and industry best practice.
A Field Safety Notice (FSN) is an urgent communication issued by a medical device manufacturer to inform customers and users about corrective actions needed to address device safety concerns. These notices are a critical part of the post-market safety system, ensuring that risks are promptly mitigated and that users are aware of any necessary actions to protect patients and staff (e.g., recalls, software fixes).
Key Elements:
Purpose: Alert users to safety problems and outline corrective steps (FSCA)
Design: Clarity and completeness matter—content should state risk nature, affected devices, and actions required.
Distribution: All impacted end-users must receive the notice; manufacturers must track receipt.
Follow‑up: MHRA may issue its own Medical Device Alert (MDA) where further action is warranted .
Effective FSNs are foundational tools ensuring immediate risk awareness, feeding naturally into broader surveillance measures.
Post-market surveillance (PMS) refers to the continuous monitoring of medical devices after they have been placed on the market. The goal is to detect, assess, and act on any issues that arise during real-world use, ensuring ongoing safety and performance.
These new requirements are legally binding from 16 June 2025 and align closely with global best practices.
Key Elements:
Mandatory PMS Systems: Every device manufacturer must implement a structured PMS system that monitors device performance throughout its lifecycle.
Data Sources: PMS must be informed by incident reports, customer feedback, scientific literature, clinical follow-up, and FSNs.
Report Outputs: Depending on the risk classification of the device, manufacturers must generate periodic summaries, trend analyses, and safety update reports.
Timely Reporting: Manufacturers are required to notify MHRA of serious incidents and corrective actions according to strict reporting timelines.
The PMS framework ensures that safety oversight continues long after a product reaches the market, enabling regulators and manufacturers to identify and address emerging risks in real time.
Custom-made medical devices are those manufactured specifically to meet the unique needs of an individual patient, based on a written prescription from a qualified practitioner. These are not mass-produced products but are tailored for a single user. Custom-made medical devices—such as dental appliances, orthopedic implants, or bespoke prosthetics—are designed to meet the specific clinical needs of individual patients. While these products differ in production from standard devices, they are still subject to regulatory expectations under the UK Medical Devices Regulations.
Key Requirements:
Definition: A custom-made device is manufactured following a healthcare professional’s prescription for a specific patient.
Labeling and Documentation: Each device must include a “custom-made statement” and technical documentation supporting its design and safety.
MHRA Registration: Even though custom-made devices are exempt from UKCA marking, they must be registered with MHRA and comply with post-market reporting rules.
Inclusion in PMS: These devices are now part of the broader PMS framework, ensuring that even one-off or low-volume products are monitored for safety post-use.
This inclusion reflects the MHRA’s commitment to maintaining high safety standards across all device types, whether mass-produced or patient-specific.
Taken together, FSNs, PMS, and custom-made device guidelines create a harmonized regulatory loop designed to monitor and improve device safety continuously. For those looking to dive deeper into the source material, the original MHRA guidance documents can be found here:
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