What's the difference between CER, SSCP and PSUR?
All medical devices on the European market must be continuously monitored, without exception, to confirm their safety and efficiency for patients and users. Clinical evaluation and post-market surveillance programs are required by the?EU MDR (2017/745)?to guarantee the safety of medical devices throughout their lifetime.
It is now required, under EU MDR and EU IVDR, for a Periodic Safety Update Report (PSUR) and Summary of Safety and Clinical Performance (SSCP). This has left many manufacturers scratching their heads as to which, if not all these documents, are needed and under what circumstances.?Seeing as all the information required for the PSUR and SSCP can also be found in the clinical evaluation report, it begs the question, what is the purpose of each report? How do they differ from one another? Do you need a Periodic Safety Update Report (PSUR) or SSCP if you have a Clinical Evaluation Report (CER)??
Read on for a break-down of not only the aspiration and content of each report, but also why both reports are needed under the?EU MDR.
Some of your documents will be made accessible to Third parties via Eudamed
It can come as quite a surprise to some, to find that their PSUR and SSCP will be uploaded onto Eudamed. Please see the flow of information and to whom it should go in the diagram below.
High-risk devices need to have their PSURs submitted via an “electronic system” – essentially EUDAMED. Consequently, Class III/Class D device PSURs, SSCP and the notified body evaluation, shall be made available to competent authorities through EUDAMED. In addition to these documents, once approved, your SSCP will also be made available to the public.
Going forwards, the Summary of Safety and Clinical Performance (SSCP) must be reviewed regularly, and updated when necessary, on EUDAMED. The aim of which is to ensure that clinical and safety information are accurate and complete. This is distinct from the PMCF evaluation report and Periodic Safety Update Report (PSUR), which are updated at least once a year.
Clinical Evaluation Report (CER) (MDR) (Note PER in IVDR)
The Clinical Evaluation Report (CER), an evaluation and conclusion of the clinical data collected for your device, is a crucial piece of the Technical Document for conformity assessment and subsequent CE Marking in Europe.
The exact function of the CER is to demonstrate the safety and efficiency of the medical device whilst delivering on clinical performance. Moreover, a Clinical Evaluation Report documents both the assessment and analysis of clinical data collected, with the purpose of verifying the clinical safety and effectiveness of the device.
The report consists of a clinical investigation of the device itself and/or existing clinical studies for comparable devices, details of which can be found in?article 61?of the MDR:?
“A clinical evaluation shall follow a defined and methodologically sound procedure based on the following:
Composing a definitive list of what should be included in the?Clinical Evaluation Report?is no easy task, when you consider the vast array of different types of medical devices out there. It goes without saying, that higher-risk devices pose a greater potential threat to a patient’s health in case of malfunction, and thus, call for a more detailed Clinical Evaluation Report than lower-risk devices.
Although no two CERs are the same, there are certain elements that should be included in all of them without fail. Including the following elements:
Though Periodic Safety Update Reports are well-known in the pharmaceutical world, they are a new requirement and therefore, somewhat of an unknown entity in the medical device industry.
Owing to a rise in unfortunate cases with medical devices that had not been monitored sufficiently, the medical device industry anticipated a stricter focus on post-market surveillance data systems with the EU MDR’s development. And, the MDR did not disappoint, putting larger emphasis on safety throughout the lifetime of the medical device. Post-market surveillance now plays a critical role in the obligations of the medical device manufacturer and a focal point in the regulation.
?Article 86?of the MDR mandates the requirement of the Periodic Safety Update Report:
?“Throughout the lifetime of the device concerned, the PSUR shall set out:
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It is imperative that the report be updated continuously throughout the lifetime of the device, from the moment it is put on the market. The Periodic Safety Update Report forms an integral part of the technical documentation submitted to the notified body during the conformity assessment.
Far from a mere repetition of the Post-Market Surveillance Report, the?Periodic Safety Update Report?is a distinct document underlining the safety of the medical device in question. Ordinarily it would include the following elements:
So, what are the differences between the CER and PSUR?
Whilst the two reports share some common elements, their purposes are very much distinct from one another.
The Clinical Evaluation Report demonstrates safety and efficiency for a?medical device’s?clinical use; Interpreting all the clinical data found on the device both before and after product launch.
Whereas the Periodic Safety Update Report is only concerned with demonstrating the safety and performance appertaining to the post-market data. In addition to this, the PSUR also aids manufacturers in demonstrating to the notified body that their post-market surveillance program uses the data available on the market to ensure the continued safety, efficacy, and performance of their device. It proves the effectiveness of a proactive post-market surveillance system.
So, what are the differences between the SSCP and PSUR?
The Summary of Safety and Clinical Performance (SSCP) is reserved exclusively for high-risk devices Class II. A robust post-market follow-up is required in?MDR 2017/745?for implantable and class III medical devices, which the SSCP forms a crucial part of. The SSCP aspires to provide healthcare workers and relevant patients access to current clinical data, in addition to other information about the safety and clinical performance of the medical device.
IVDR?Article 29?of the European In Vitro Diagnostics Regulation 2017/746 (EU IVDR) describes a requirement akin to the SSCP: the Summary of Safety and Performance (SSP) for Class C &D. Almost identical to the requirements of the SSP, however, replacing ‘clinical’ with ‘performance’ evaluation, and including requirement for metrological traceability of assigned values. it is likely that?MDCG 2019-9?will be used as a model for SSP guidance, considering the pressure on commission expert groups to draft guidance documents. Therefore, IVDR manufacturers might want to take a sneak preview in order to prepare themselves for what is to come.
The SSCP should have two parts. The first for healthcare professionals, and the second for patients. The challenge here being a writeup that targets both audiences. Such writeups call for medical writers that possess both strong technical writing skills and the ability to transform complex scientific information into easy-to-read content.?There are 9 sections that need to be addressed in the SSCP:
It is important to bear in mind that, even though the SSCP provides information in abundance,?MDCG 2019-9?clearly states that SSCP is not intended to:
?On the following page, you will find a summary of the elements included in each report, and below that, are the all-important guidelines for keeping each report updated.
CER Updates:?Class I should be updated when needed. Class II requires updating every 2 to 5 years. Class III must be updated annually. Class A & B devices can be updated as needed. And lastly, Class C & D devices must be updated at least every year. All classes need to be updated due to new information changing the benefit to risk or if new risks arise.
PSUR Updates:?The Periodic Safety Update Report is part of a device’s technical documentation, and it must be updated throughout the device’s lifecycle.
SSCP Update:?The SSCP is part of a device’s technical documentation, and it must be updated to reflect on the current changes made to the PER or CER that affects the benefit-to-risk of the device
CLIN-r+ Recommendation:
These reports should be considered a workstream of data by manufacturers, and one that requires reporting across many areas in various ways. The diagram below demonstrates the flow of data required under MDR and IVDR. Facilitating this can bring changes to not only an organisation’s IT infrastructure, but also, work roles and interdepartmental collaboration.
Substantial pressure has been put on medical device manufacturers, owing to the implementation of the?EU MDR?in May 2021 and its emphasized focus on efficient clinical evaluation and post-market surveillance systems. How, where, and when to adapt internal infrastructure in order to streamline the work, will become a considerable part of the regulatory work related to medical devices pre- and post-launch. This is largely due to the notified bodies being ever more vigilant in their reviews of QMS systems, engineering reports and ensuring compliance to clinical and post-market requirements.
These requirements can be challenging, and if your team is struggling, CLIN-r+ team can help with planning your technical documents, formulating supportive workflows (QMS SOP’s), and working with your team to streamline this change. Initially, where there may not be enough resources at your disposal, count on CLIN-r+ to form part of your organisation at that time to ensure the workflow progresses and that you can meet the full MDR/IVDR transition on time. Interested??Let’s talk!?????????