Overview:
PSUR, as outlined in Article 86 of the MDR and Article 81 of the IVDR, is a critical document that provides comprehensive information on the safety, performance, and benefit-risk profile of a device throughout its lifecycle.
PSUR is a living document, continually updated to reflect new findings from post-market experience. For manufacturers, PSUR not only acts as a tool for regulatory compliance but also plays a vital role in their internal quality assurance and risk management practices.
PSUR aims to enhance patient safety, regulatory oversight, and public transparency, making it integral for manufacturers as they adapt to the more stringent requirements of MDR and IVDR.
The MDCG 2022-21 guidance document outlines the structure and requirements of PSUR, which is mandatory for Class IIa, IIb, and III medical devices and Class C and D in vitro medical devices.
What are the key requirements of the PSUR?
a) Device-Specific Reporting Frequency:
- Class IIa Devices: PSURs must be updated at least every two years, though real-world safety issues may demand more frequent updates.
- Class IIb and Class III medical devices and Class C & D in vitro medical devices: PSURs must be updated annually.
These reports must be reviewed by notified bodies (NBs) for Class IIb and III medical devices and Class C in vitro medical devices. For Class III and implantable medical devices and Class D in vitro medical devices, PSURs will also be accessible through the EUDAMED database, once available, which enhances transparency for healthcare providers and the general public.
b) PSUR Structure and Content:
Do new risks need documenting?
Yes, New risks or concerns identified during PMS activities must be documented and evaluated to ensure transparency. The PSUR emphasises a proactive approach to assessing device safety. Manufacturers are required to continuously evaluate whether the device’s risk-benefit profile remains favorable, supported by concrete PMS data and clinical findings.
Should PSURs be accessible?
The MDR and IVDR requires that PSURs for Class III and implantable medical devices and Class D in vitro medical devices respectively, be accessible to the public via the EUDAMED database, once available, increasing transparency and public trust in the safety of medical devices.
Is the PSUR linked to the PMCF / PMPF?
Yes, the PSUR is closely linked to the post-market clinical follow-up (PMCF) plan or post-market performance follow-up (PMPF). PMCF / PMPF activities should be included in the PMS system and any findings should feed directly into the PSUR, thereby ensuring a dynamic approach to clinical evidence generation and benefit-risk reassessment over the device’s lifecycle.
What are the benefits of the PSUR in the context of the MDR / IVDR?
- Improved Patient Safety: By rigorously monitoring devices post-market, manufacturers can identify and address potential risks before they result in adverse events.
- Strengthened Benefit-Risk Profile: PSUR enables manufacturers to continuously assess the benefit-risk balance, ensuring the device’s clinical benefits outweigh potential risks.
- Increased Transparency and Accountability: PSUR makes critical safety and performance data accessible, strengthening public trust in medical devices.
What are the challenges and common pitfalls?
- Data Overload: Given the requirement to collect a large volume of post-market data, managing and processing this information efficiently can be a challenge.
- Consistent Terminology and Reporting Standards: Differences in terminology or reporting practices can make it challenging to interpret data across regions or departments.
- Resource Constraints: Developing and maintaining PSURs can require significant time and expertise.
How can Advena Ltd help?
- Robust Documentation Preparation – help prepare thorough and well-structured PSURs. Research, collect and present all relevant post-market data to assess your device’s safety and performance.
- Access to a network of clinical study experts – if additional clinical data is required, assist with reviewing, planning and conducting pre (clinical / performance investigations) and post market (PMCF / PMPF) studies.
- Comprehensive GAP Analysis – Assessing the quality, relevance, and completeness of the data/document.
In addition, we can also provide:
- Full technical documentation review/creation
- Assistance with regulatory submissions and interactions with regulatory authorities
- Training/knowledge transfer
- ISO13485 Quality Management System creation, management and support
Contact Us
For further information and personalised guidance, please feel free to reach out to Advena via either our website contact page, www.advenamedical.com, email (info@advena.com) or phone (01926 800153) to start a conversation today.
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