The long awaited MDCG 2022-21 has been finally published and preparation of the Periodic Safety Update Report became much easier. One of the most significant changes related to the EU MDR 2017/745 and IVDR 2017/746 is post-market surveillance, where multiple additional requirements have been introduced for the manufacturers. We have already been extensively discussing about different topics of post-market surveillance, such as vigilance reporting, PMS Plan, trend reports, summary of safety and clinical performance, and ISO 20416.
Objectives of the PUSR as per MDCG 2022-21
The PSUR serves two primary purposes:
1) Identifying and evaluating changes in the benefit-risk profile: It summarizes post-market surveillance data to detect any alterations in the benefit-risk profile of medical devices. Manufacturers use this information to reassess device safety and effectiveness, aligning with MDR objectives. The PSUR also ensures transparency by providing comprehensive data to Notified Bodies and Competent Authorities.
2) Reporting Preventive or Corrective Actions (CAPA) as per Article 83(4): The PSUR informs authorities about CAPAs, including serious incidents and safety corrective actions. CAPAs cover issues directly impacting device safety, performance, or quality, excluding quality management system-related matters unless they directly affect product quality. Safety-related CAPAs must be included in the PSUR.
Please note that an in-depth online and self-paced training of about 4 hours focused on postmarket surveillance topics has been developed by QualityMedDev Academy and it is fully available at this link (click in the image below for a full description of the course):
Brief Overview of PSUR Contents
As per Article 86(1) of the MDR, the PSUR is required to provide a condensed overview of the analysis conducted on post-market surveillance data gathered through the PMS Plan. According to MDCG 2022-21, this summary should encompass:
- Conclusions drawn from the benefit-risk assessment.
- Key findings from the Post-Market Clinical Follow-up (PMCF).
- Sales volume of the device and an estimated evaluation of the user population, including usage frequency.
To compile this summary, the following aspects should be taken into account:
Further guidance on collecting relevant data and presenting/evaluating it is provided in Annex I and Annex III of this guidance document.
Devices within the Scope of the PSUR according to MDCG 2022-21
Article 86 mandates that manufacturers of class III, class IIb, and class IIa devices must develop a Periodic Safety Update Report (PSUR) for each device, and where applicable, for each category or group of devices. This requirement extends to:
- Devices compliant with the MDR: Including class IIa, class IIb, and class III devices certified according to MDR requirements, regardless of whether they were placed on the market before or after the Date of Application (DoA) of the MDR, which was 26th May 2021.
- Custom-made devices falling within class IIa, class IIb, and class III, provided they meet MDR requirements.
- Annex XVI devices falling within class IIa, IIb, and class III categories, upon the MDR’s applicability to those devices.
The term “legacy devices” encompasses devices that were placed on the market before the MDR’s date of application (DoA), recognizing that “device” in this context refers to a device model rather than individual devices. This scope includes all devices for which at least some individual units were placed on the market before the MDR’s DoA, as permitted under Article 120(3) of the regulatory regime.
Overview of the Requirements for PSUR preparation
The manufacturer bears the responsibility for crafting and maintaining PSURs, integrating them into the technical documentation as outlined in Annex III of the MDR, and in Annex XIII for custom-made devices (CMD).
Data Collection Period, Issuance Timeline, Submission, and PSUR Schedule: Commencing from the MDR certification date of the device, the data collection period should initiate. In cases where the device lacks MDR certification, the period starts from the MDR Date of Application (26th May 2021). Notably, for the initial PSUR, historical data from pre-Date of Application or MDR Device Certification activities may support data analysis. Furthermore, the first PSUR may not strictly adhere to 12 or 24-month data collection periods to ensure continuity, avoiding gaps or overlaps. Subsequent PSURs may cover varying periods as necessary, with each data collection period aligning seamlessly with the next.
PSUR Preparation and Issuance Timeline: The PSUR preparation and issuance timeline denotes the duration required by the manufacturer to prepare and submit or make available the PSUR after the data collection period’s conclusion.
PSUR Submission/Issuance: Depending on the device’s class, as per Article 86(2), the manufacturer must either submit the PSUR to the Notified Body via EUDAMED or provide it to the relevant Notified Body involved in conformity assessment.
Schedule for PSUR Updates: The schedule encompasses the recurring cycle for initiating and concluding each PSUR’s data collection period, as well as preparing and submitting or providing the PSUR post-data collection.
Continuity of Schedule with MDR Certification of Legacy Devices: If an MDD-compliant device transitions to MDR certification without significant changes per Article 120(3), the initial PSUR schedule under the Article 120(3) regime may persist, albeit with potential misalignment with the MDR certification date. Conversely, if significant changes occur, rendering the device effectively new, a fresh schedule must commence based on the MDR certification date, unless otherwise agreed between the manufacturer and the Notified Body.
We have developed a PSUR Template fully aligned with the requirements of MDCG 2022-21 and the requirements of EU MDR and IVDR. This is a word document, fully editable, which would just need to be completed with the information related to devices under evaluation. Have a look to this template :
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PSUR report Template€64,00
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