The MDR requires manufacturers of class IIa, class IIb, and class III devices to prepare and submit a Periodic Safety Update Report (PSUR) at least annually for each medical device. Manufacturers of class I devices do not have to prepare a PSUR: instead, they should prepare a Post-Market Surveillance (PMS) Report.
PSUR is a report that summarizes the results and conclusions of the analysis of post-market surveillance data gathered as a result of the PMS Plan for medical devices. PSUR must be updated whenever there are new safety information or significant changes in the benefit/risk assessment of the device. Manufacturers are required to submit PSURs for medical devices through the EU database EUDAMED, ensuring PSURs are in compliance with EUDAMED requirements, annually for class IIb and class III devices and every two years for class IIa devices. Manufacturers of legacy devices should not submit PSUR in EUDAMED but should make it available upon request to Competent Authorities and Notified Bodies.
The MDCG 2022-21 “Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 (MDR)” of December 2022 provides valuable information on how to prepare a PSUR that meets the requirements of the MDR. This guidance is applicable to medical devices which have been certified under MDR or MDD 93/42/EEC or AIMDD 90/385/EEC. It does not apply to in vitro diagnostic medical devices which have been certified under IVDR (EU) 2017/746 or IVDD 98/79/EEC.
MDCG guidance also includes a template for the presentation of data in the PSUR, that offers a recommended structure for presenting the PSUR, designed to ensure that the information required by the MDR is included in a complete and consistent manner, with specific sections for device description, post-market surveillance data, Field Safety Corrective Actions (FSCAs) and Corrective and Preventive Actions (CAPAs) initiated, and other relevant information, simplifying the preparation of PSURs by Manufacturers and also the review process by competent authorities.
Regulatory Pharma Net (RPN) has extensive experience in regulatory affairs and can provide expert advice on how to meet regulatory requirements, being available to provide your company with any updates on the device regulatory framework and to assist on all regulatory needs including the preparation of PSURs for your medical devices.
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