Periodic Safety Update Report (PSUR) and Summary of Safety and Clinical Performance (SSCP) / Summary of Safety and Performance (SSP)
[Contenuto in lingua inglese]
Date: 15 May 2023
Article 86 of EU MDR 2017/745 requires manufacturers of Class IIa, IIb and Class III devices to generate a PSUR and Article 81 of EU IVDR 2017/746 requires manufacturers of Class C and D devices to generate a PSUR.
When available, the PSUR and Notified Body evaluation report for Class III and Implantable and Class D devices will be uploaded to the European Database on Medical Devices (EUDAMED).
Legacy device PSURs (MDR)
MDCG 2021-25 states that manufacturers of legacy devices (those that are continued to be placed on the market during this transitional period under MDD/AIMDD) should NOT submit their PSUR to the Notified Body for evaluation unless requested.
For MDD/AIMDD devices the Notified Body shall confirm through quality management audits that the manufacturer is generating a PSUR and has modified their post-market surveillance (PMS) system to meet the new requirements for the MDR/IVDR.
Legacy device PSURs (IVDR)
MDCG 2022-08 states that manufacturers of IVD legacy devices (those that are continued to be placed on the market during this transitional period under IVDD) should continue to prepare a PMS Report and may voluntary prepare a PSUR if desired.
Per MDCG 2022-08: “As Directive 98/79/EC, contrary to the IVDR, does not provide for rules for the classification of devices in risk classes as specified in the IVDR, an appropriate distinction cannot be made between ‘legacy devices’ to which Article 80 IVDR (PMS report) and ‘legacy devices’ to which Article 81 IVDR (periodic safety update report, PSUR) apply. Therefore, Article 80 IVDR (PMS report) should, as a minimum requirement, apply to all legacy devices, unless a manufacturer of ‘legacy devices’ that will fall under class C or D voluntarily prepares a PSUR pursuant to Article 81.”
So, since under the old classification mechanism it is not possible to determine if a device falls into Class A, B, C or D, the minimum should be the PMS Reports under the IVDD. These PMS reports or PSURs should NOT be submitted to the Notified Body unless requested.
The Notified Body Evaluation Process of the PSUR for MDR/IVDR Certified Devices
- Class III and Implantable devices (MDR)/Class D devices (IVDR)
In the absence of EUDAMED, manufacturers of Class III and Implantable/Class D devices will need to submit the PSUR to the Notified Body through the BSI Electronic Client Portal. This should be performed annually for Class III, IIb and Class D devices and every other year for Class IIa devices.
A technical specialist or clinical evaluation specialist will perform the evaluation of the PSUR.
Please note that during the evaluation process there will be no rounds of questions therefore it is essential that the manufacturer ensures the contents of the PSUR aligns with the MDCG guidance template provided in MDCG 2022-21, and that any anomalies within the PSUR are clearly explained and supported with a description of all actions being taken by the manufacturer to address these anomalies.
Any absence of data within the PSUR that is requested by the MDCG template should be justified within the PSUR. The contents of the PSUR should contain at minimum the following sections and accompanying data:
- Volume of Sales by region over time
- Estimated size of the patient population using the device over time
- Characteristics of the population using the device* over time
- Post-Market Surveillance: Vigilance and CAPA information
- Post-Market Surveillance: information including general Post-Market Clinical/Performance Follow-up (PMCF) information
- Summary of Findings and conclusions
- Actions taken by the manufacturer (If any -this may include updates to SSCP/SSP)
Failure to provide the minimum information within the contents of the PSUR may result in the PSUR being rejected by the evaluator and the manufacturer will be requested to resubmit a revised version within 30 days. Failure to continually submit the minimum required information in the PSUR or failure to submit a PSUR may lead to suspension and/or withdrawal of the certificate.
At the end of the PSUR evaluation process, the manufacturer will receive a copy of the PSUR evaluation report. There will be no updates to the certificate from the PSUR evaluation process.
If concerns are identified with the data, conclusions, or the benefit/risk determination within the PSUR, the evaluator will end the evaluation process and will need to initiate a technical documentation assessment for further analysis of the benefit/risk profile of the device. In this situation the manufacturer will be informed, and standard quotation procedures will apply.
Where there are improvements needed to enhance the data within the PSUR, but no immediate concerns on the data, conclusions or the benefit/risk determination, the evaluator may provide feedback within the PSUR evaluation report requesting the manufacturer provides additional information/data for future PSUR submissions. It is critically important the manufacturer addresses this feedback for the next PSUR submission to avoid potential suspension and/or withdrawal of the certificate.
- Class IIa and IIb Non-Implantable (MDR) /Class C devices (IVDR)
Manufacturers of Class IIa and IIb non-implantable and Class C devices are also required to generate a PSUR. This shall be generated annually for Class IIb devices and Class C devices and every other year for Class IIa devices. The PSUR and evaluations will not be uploaded to EUDAMED but should be made available to Notified Bodies and Competent Authorities upon request.
For this classification of device, the PSUR shall be submitted as part of technical file surveillance and will be considered within those assessments. The PSUR should be submitted alongside all other technical documentation through the already agreed submission process.
A standalone PSUR evaluation report for these devices will not be provided to the manufacturer for these devices and the PSUR evaluation will be reported within the notified body’s Clinical Evaluation Assessment Report (CEAR).
Submitting an updated SSCP/SSP with PSUR (Class III and Implantable/Class D device only)
Article 61 (11) of the EU MDR/ Article 56 (6) of the EU IVDR describe that the SSCP/SSP shall be updated if indicated/when necessary. Data and conclusions identified from the PSUR may trigger an update to the SSCP/SSP.
The Notified Body will aim to evaluate the PSUR as soon as possible and we will also use this opportunity to validate updates from the PSUR to the SSCP/SSP.
Please note that it may be justified by the manufacturer that an SSCP/SSP may not need to be sent to the Notified Body for validation if the safety or performance information of the device remains unchanged and there is no new helpful information for the healthcare professional/patient/user.
Please ensure the revised SSCP/SSP is also submitted alongside the PSUR through the BSI Electronic Client Portal. When making any updates to the SSCP/SSP please provide both a redline version and a final version of the document.
Updates may be required from the PSUR to the SSCP/SSP, these may include: (Note this is not an exhaustive list)
- New, emerging or changed risks identified from PMS/PMCF/PMPF
- Changes to the expected performance of the device
- Results from a completed PMCF/PMPF activity
- Initiation of a new specific PMCF/PMPF
Please note validation of updates to the SSCP/SSP at time of the PSUR evaluation will be limited to the contents and scope of the PSUR evaluation.
Updates to the SSCP/SSP that require validating and are outside the scope of the PSUR evaluation will require additional technical documentation to be submitted to perform the validation (e.g., CER, PMCF/PMPF plans) and therefore will need to be performed as a separate technical documentation assessment. These changes cannot be performed at time of PSUR evaluation.
Please speak to your scheme manger if you require updates to the SSCP/SSP to be validated that are outside of the contents of the PSUR.
Please note that in line with MDCG 2019-9 (SSCP) and MDCG 2022-21 (SSP) administrative/editorial updates that do not impact the clinical data should be postponed until the next available opportunity. Editorial updates that have no impact on the clinical/performance data in the SSCP/SSP can be considered for validation at time of PSUR evaluation.
Please do not submit any translations through the BSI Electronic Client Portal unless requested to do so by BSI. We are awaiting further guidance from the EU Commission on the upload of translations into EUDAMED.
If during the Notified Body evaluation process of the PSUR and/or validation of the SSCP/SSP you wish to submit any updated revisions of your documents, please DO NOT submit through the BSI Electronic Client Portal, instead please contact your Scheme Manager as we will need to confirm if the review has commenced and whether it is still possible to submit any updates at the point of the assessment.
Find out how to upload the PSUR and SSCP/SSP to the BSI Electronic Client Portal.
For more information on BSI expectations of PSUR and SSCP/SSP submissions, please listen back to our recent webinar.
Richard Holborow - Head of Clinical Compliance
Alex Laan - Head of IVD, Notified Body