What is a Periodic Safety Update Report (PSUR) for Medical Devices?
In the evolving regulatory landscape of medical devices, maintaining post-market vigilance is paramount. Among the essential elements of this framework is the Periodic Safety Update Report (PSUR), a critical requirement outlined under the European Union’s Medical Device Regulation (MDR). This report ensures ongoing safety and compliance while fostering transparency and accountability among manufacturers.
What is a PSUR?
The PSUR is one of the two pivotal reports mandated for post-market surveillance by medical device manufacturers. It is essentially a periodic summary that consolidates the outcomes of post-market surveillance activities and the corresponding conclusions drawn by the manufacturer. These include corrective or preventive actions (CAPAs) taken, with detailed descriptions and rationales. The PSUR serves as a mechanism to assure regulators and stakeholders that the medical device remains safe and effective throughout its lifecycle.
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Who Needs to Prepare a PSUR?
Under Article 86 of the MDR, the PSUR is mandatory for specific categories of devices, ensuring compliance with stringent safety standards. These include:
- MDR-compliant devices of Class IIa, IIb, and III.
- Custom-made devices are falling under the higher risk categories.
- Annex XVI devices classified as IIa, IIb, or III.
- Legacy devices under MDR, following the transition from previous directives like MDD and AIMDD.
Manufacturers of these devices must update and maintain PSURs as per their classification and make them available to Notified Bodies and competent authorities as required.
Exceptions:
Class I devices (both legacy and MDR-compliant) are not required to have a PSUR. Instead, they must prepare a Post-Market Surveillance (PMS) Report, which is updated as necessary.
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9 Key Rules for PSUR Compliance
To ensure regulatory alignment, manufacturers must adhere to the following nine rules:
- Organized Data Representation: Clearly present data for each Basic UDI-DI.
- “Leading Device” Designation: Assign a leading device from the highest risk class to guide the PSUR schedule.
- Unified Schedule: The leading device dictates the PSUR timeline for the entire group.
- Consistency in Requirements: Match PSUR requirements for all devices in the group with those of the leading device.
- Device Group Modifications: Device groupings in a PSUR can be adjusted, except for the leading device.
- Updates for Changes: Issue a new PSUR for any change in the leading device.
- Continued Updates: Keep updating PSURs for groups with former leading devices.
- Uniform Review Process: Group devices in a PSUR only if reviewed by the same Notified Body.
- Cross-Notified Body Actions: Include actions and references from previous PSURs when devices are assessed by different Notified Bodies.
By following these guidelines, manufacturers can demonstrate compliance and facilitate seamless surveillance audits.
How Operon Strategist Supports Manufacturers
As a trusted name in regulatory consulting, Operon Strategist plays a pivotal role in helping manufacturers navigate the complexities of PSUR preparation and compliance.
- Expert Guidance: Operon Strategist ensures clarity in understanding and implementing the MDR requirements, reducing the burden on manufacturers.
- Streamlined Processes: The team assists in organizing and presenting PSUR data effectively, adhering to all nine compliance rules.
- Risk Mitigation: With Operon’s strategic support, manufacturers can proactively address compliance gaps and minimize regulatory risks.
- Comprehensive Solutions: Operon’s expertise extends across a wide range of devices, offering tailored solutions for both legacy and MDR-compliant products.
By choosing Operon Strategist, manufacturers gain a reliable partner dedicated to ensuring regulatory success and market readiness. Their proactive approach transforms challenges into opportunities, empowering businesses to thrive in the global medical device market.
