Author: Suzanne Broussard
The Summary of Safety and Clinical Performance (SSCP) plays an important part of the very strong post-market follow-up required in MDR 2017/745 for implantable and class III medical devices. The SSCP is intended to provide healthcare workers and relevant patients access to current clinical data and other information about the safety and clinical performance of the medical device.
SSCP is 1 of 2 yearly reports required of manufacturers to remain complaint under MDR to market medical devices in the European Union. The 2 reports are the Product Safety Update Report (PSUR) and the Summary of Safety and Clinical Performance (SSCP). The SSCP is not the same as the regular CER update. The SSCP needs to be updated when the PMCF and PSUR are updated as part of the ongoing lifecycle of these regulatory documents.
The specific requirements of the SSCP can be found in Article 32 of MDR 2017/745. In addition, the European Union released MDCG 2019-9: Summary of safety and clinical performance, A guide for manufactures and notified bodies to provide guidance on the presentation of content in the validation of the SSCP.
The guidance document outlines the minimum content required, and the manufacturer is encouraged to include additional information to enhance the readers understanding of the device’s safety and performance. Of course, the additional information cannot include promotional material and should not interfere with readability. Manufacturers should also keep in mind that the SSCP must be validated by notified bodies (NB); the guideline also provides information for NBs that the manufacturer can use to ensure that the SSPC includes all the relevant information.
Another point to consider is that the target audience is healthcare workers as well as relevant patients. The European Commission considers relevant patients the target audience in special circumstances where the patient is directly engaged in the use of the device, such as implantable devices for which patients will be given an implant card and class III devices that are intended to be used directly by the patient.
However, once the European Database on Medical Devices (Eudamed) database goes live May 26, 2022, the SSCP can be accessed by anyone and everyone.
The SSCP should always have 2 parts. One part for healthcare professionals, and a second part for patients. Ensuring the SSCP includes a writeup that targets both audiences requires medical writers with strong technical writing skills and writers that transform complex scientific information into easy to read content.
The SSCP has 9 sections that need to be addressed:
1. The identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN (single registration number)
2. The intended purpose of the device and any indications, contraindication and target populations
3. A description of the device, including a reference to previous generations(s) of variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device.
4. Information on any residual risks and any undesirable effects, warnings and precautions
5. The summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up
6. Possible diagnostic or therapeutic alternatives
7. Suggested profile and training for users
8. Reference to any harmonized standards and CS applied
9. Revision history
While the SSCP provides a plethora of information, MDCG 2019-9 clearly states that SSCP is not intended to:
- give general advice on the diagnosis or treatment of particular medical conditions, nor
- replace the instructions for use (IFU) as the main document that will be provided to ensure the safe use of a particular device, nor
- replace the mandatory information on implant cards or in any other mandatory documents.
Unlike the Post-Market Clinical Follow-Up (PMCF) plans and report, the SSCP is only required for implantable and class III medical devices. Custom made and investigational devices are the exceptions that do not require an SSCP.
The data needs to be presented in an objective manner that clearly summarizes both favorable data and unfavorable data. Putting together an SSCP that includes the devices benefit to risk, diagnostic and therapeutic alternatives as well as the specific conditions in which the device is considered can be a real challenge. All SSCPs need to be entered into the Eudamed. The fact that SSCPCs will be available to the public as soon as Eudamed is updated and goes live in 2022 puts even more pressure on getting the SSCP right.
Criterion Edge works with experienced medical writers to help ensure that the critical SSCP elements, such as the source of quality data, are correctly disclosed in the SSCP. Chat with us about our experience with SSCPs.
Author: Suzanne Broussard
Is your organization ready to display to the world your medical devices safety and performance record? The Summary of Safety and Clinical Performance (SSCP) is one of the new requirements imposed by manufacturers by the European Commission in Medical Device Regulations (MDR)2017/745 for implantable devices and class III devices. And, SSPC will go virtual when EUDAMED roles out in 2022.
The SSCP is intended to provide intended users (healthcare professionals, and if relevant patients) with an updated summary of the device’s safety, clinical data, and clinical performance. This enhanced transparency provides everyone with adequate access to the devices clinical data, including your customers and your competitors.
The SSCP should be sourced directly from the technical documentation, including the clinical evaluation report (CER), post-market surveillance, and post-market clinical follow-up (PMCF). And, the SSCP “shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (EUDAMED).” The SSCP must be updated at least annually.
There are added benefits to making the SSCP public knowledge that can benefit manufacturers. Organizations can utilize the public information to their advantage. For example, manufacturers can use competitors SSCPs to:
- Justify their devices proposed pre-market and post-market studies
- Understand other devices strengths and weaknesses to improve your device
- Justify risk
- Increase market awareness
Deadlines Extended to Allow Citizens Time to Safely Respond to the COVID-19 pandemic.
The European Commission has proposed to extend the deadline for MDR compliance by one year (at this time waiting for approval by member states and publication in the Official Journal). The launch of EUDAMED has also been delayed. Now, EUDAMED will be launched together with the in-vitro medical devices in May 2022.
The SSCP is still required to be part of MDR 2017/745 even though the launch of EUMADED has been moved back.
A silver lining to the current health crises is that medical device manufacturers now have more time to become fully compliant with the European Commission regulations.
The European Commission provided guidelines in September of 2019 on the presentation, content, and validation of the SSCP to fulfill the objectives of MDR in MDGC 2019-9. That guidance document can be accessed here.
Since the EUDAMED’s live rollout has been officially delayed by 2 years, intended users and manufacturers will have to wait until May 26, 2022 to access the treasure trove of data.
Including the SSCP into the MDR 2017/745 was primarily intended to provide healthcare providers with current data to allow them to make informed decisions for patient treatment options. However, this level of transparency has the potential to change the playing field for medical device manufacturers in unforeseen ways.
With healthcare professionals and competitors looking at your organizations SSCP, it is important that they are not only technically correct but also polished. This may be challenging for many manufacturers to get the technical documents up to speed, even with the possible 1-year MDR extension*.
* MDR deadline has been extended one year to May 26th, 2021
If you would like some guidance with the SSCP, PMCF, CER, or other technical documents, please reach out to our experts at Criterion Edge.
Get a copy of the slides from this webinar or click to watch the recording.
In this first installment of a 2-part webinar series, Criterion Edge will present strategies for assessing key components of your CER (or CER template) for possible misalignment with significant and applicable MDR requirements. Presented from the perspective of seasoned regulatory writers with deep experience developing MDR compliant CER templates and recent authorship of MDR-ready CERs, this practical presentation will help you assess your document through the critical lens of a writer and identify possible gaps for mitigation before submission to regulatory authorities.
Key Takeaways:
• Identify key MDR requirements that are applicable to critical components of a CER
• Apply review strategies to help evaluate your CER for alignment with MDR requirements
• Why organization, structure and clear language really matter in your CER
Who should watch this webinar?
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Clinical Evaluation Reports for EU MDR submission, or anyone interested in learning more about MDR requirements for CERs.
Sign up for future webinars here.
If you enjoyed this webinar and would like a free consultation, please contact us here.
Author: Suzanne Broussard
Post-market clinical follow-up (PMCF) requirements have increased under the newest Medical Device Regulations (MDR) 2017/745. All medical devices will be required to meet these standards, and the deadline is here. The possible 1-year extension for the application of MDR might give manufacturers a little wiggle room to achieve compliance, but not much.
The European Commission (EC) states in a nutshell that one of the reasons for the new regulations is to strengthen post-market surveillance requirements for manufacturers.
The goals for these new regulations are to:
- Improve the quality, safety, and reliability of medical devices
- Strengthen transparency of information for consumers
- Enhance vigilance and market surveillance
The EC considers these newest regulations as providing extremely important improvements to modernize the current system and, therefore, medical device manufacturers need to make every effort to be compliant or risk further delays in obtaining a CE marking for their device.
In a recent post, we discussed one of the most challenging areas in the CER: Defining Measurable Safety and Performance Endpoints.
The PMCF plan must establish processes that proactively and systematically collect information from a variety of sources. These sources include serious incidents, Periodic Safety Update Reports (PSUR), field safety corrective actions, inputs on non-serious injury, undesirable side-effects, trend reports, literature, databases, registers, feedback and complaint sources form users, distributers and importers, as well as publicly available information on similar medical devices (MDR 2017/745, Annex III).
The PMCF plan should document the method in which the PMCF should be performed. Therefore, the PMCF plan needs to specify the methods and procedures that will be used by the manufacturer to proactively collect the clinical data and the data’s subsequent evaluation. The plan’s aims are to:
- Confirm the safety and performance of the device throughout its expected lifetime,
- Identify previously unknown side-effects and monitoring the identified side-effects and contraindications,
- Identifying and analyze emergent risks on the basis of factual evidence,
- Ensure the continued acceptability of the benefit-risk ratio referred to in Sections 1 and 9 of Annex I, and
- Identify possible systematic misuse or off-label use of the device with a view to verify that the intended purpose is correct.
Choosing the post-market data to be collected in the PMCF plan is not an easy or straightforward task. The plan must include pertinent parameters to ensure the device is safe and effective. However, including too many or irrelevant variables may result in low response rates and/or missing data. The manufacturer should also consider that some data will be visible to the public. Indeed, one of the goals of the new regulations is to introduce transparency into the system to keep the general public informed, allowing patients to be more engaged in making their healthcare decisions.
The PMCF plan plays a central role under MDR 2017/745 since it lays the groundwork for the PMCF studies that subsequently interface with PSUR, Summary of Safety and Clinical Performance (SSCP), risk management files, CER updates, labeling, and IFU.
The data acquired through the application of the PMCF plan can provide strong evidence as to the safety and efficacy of the device and details about the clinical risks associated with use. Analysis of these post-market clinical data in combination with clinical literature is a powerful tool for manufacturers to improve product performance and support claims to regulatory agencies.
Getting these done is very time consuming and requires significant expertise, especially since the PMCF plan is an integral part of the quality system under MDR. The level of specificity necessary for the methods and protocols is intense.
The PMCF Plan must, at the very least, include the following:
- (a) The general methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data;
- (b) The specific methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained feedback from users, screening of scientific literature and of other sources of clinical data;
- (c) The specific methods and procedures of PMCF to be applied such as evaluation of suitable registers or PMCF studies;
- (d) A rationale for the appropriateness of the methods and procedures referred to in points (a) and (b);
- (e) A reference to the relevant parts of the clinical evaluation report referred to in section 4 and to the risk management referred to in Section 3 of Annex I;
- (f) The specific objectives to be addressed by the PMCF
- (g) An evaluation of the clinical data relating to equivalent or similar devices;
- (h) Reference to any relevant CS, harmonized standards when used by the manufacturer, and relevant guidance on PMCF; and
- (i) A detailed and adequately justified time schedule for PMCF activities (e.g. analysis of PMCF data and reporting) to be undertaken by the manufacturer.
At Criterion Edge, we understand how important the PMCF plan is to the success of your device’s new or annual CER and, thus, ultimately compliance with regulatory authorities and marketing in the European Union. Our experienced medical writers can provide guidance and expertise on the PMCF plan or any other aspect of your CER. If your organization needs expertise or just some breathing space for your medical writers, please reach out to us to chat.
Author: Suzanne Broussard
Performing a methodologically sound literature review in the early stages of product development, as well as in the later stages, can help reduce most of the inadequacies highlighted by the European Commission in section A6 of MEDDEV 2.7/1 revision 4. Section A6 provides examples of studies that lack scientific validity for the demonstration of adequate clinical performance and/or safety.
Here are the seven areas highlighted in section A6 of MEDDEV 2.7/1 revision 4 that manufacturers tend to have the most problems in proving scientific validity:
- Lack of information on elementary aspects: This includes missing elementary requirements of the clinical evaluation such as methods, results of clinical studies, observed undesirable side effects, and details on the intend-to-treat population.
- Numbers too small for statistical significance: This may include publications and reports with “inconclusive preliminary data, inconclusive data from feasibility studies, anecdotal experience, hypothesis papers and unsubscribed opinions.”
- Improper statistical methods: The examples given are centered around 3 scenarios. 1) No corrections applied to multiple comparisons. 2) Calculations and test were used that are based on a certain type of distribution data while the distribution is not tested, not plausible, or data were not transformed.
- Lack of adequate controls: It is possible to cause bias or confounding in single arm-studies and in other studies that do not include appropriate controls in the following situations: results based on subjective endpoint assessments, endpoints subject to natural fluctuations, studies with subjects that are likely to take effective co-interventions, other influencing factors, or when publications indicate there may be variables and ill controlled factors.
- Improper collection of mortality and serious adverse events data: In situations where mortality studies and other studies that may result in serious outcomes, there must be procedures in place to “investigate serious patient outcomes, numbers of subjects lost to follow-up, reasons why subjects leave the study, and the results of sensitivity analysis should be fully disclosed in reports and publications.”
- Misinterpretation by the authors: Conclusions must be in line with the results section.
- Illegal activities: All clinical investigations must be in compliance with local regulations, as well as designed, conducted, and reported in accordance with EN ISO 14155 or a comparable standard, and the Declaration of Helsinki.
In a recent post, we talked about one of the most challenging areas of the CER: Defining Measurable Safety and Performance Endpoints
The first deficiency listed, “lack of information on elementary aspects,” can obviously be improved using a robust systematic literature review. Defining the evaluation criteria is the first step in performing a methodologically sound systematic literature review, and these sections would then fall into place. For example, one criterion would define the clinical study methods, while other criteria might include clearly defining results to be included, undesirable side effects, and the intended-to-treat population. A scientifically sound approach and well-organized data management plan can bring all the clinical data together and allow for a thorough understanding of where the device is in the process of obtaining an CE marking.
Less obvious is how a methodologically sound systematic literature review can help with some of the other CER deficiencies. Let’s look at the three points in a devices lifecycle in which clinical evaluation is undertaken: development of the medical device (section 6.2.1), initial CE-marking (section 6.2.2), and updating the clinical evaluation (section 6.2.3).
The systematic literature review can be an effective tool early in the development of the medical device for gap analysis and determining State-of-the-Art. Once all the clinical evidence is gathered it is much easier to see if the publications and report documents have conclusive preliminary data or if further clinical data is required before moving forward with CER submissions. And, closely evaluating the complied data makes it easier for manufacturers to note statistical methods in the supporting data, and the potential of bias.
Of course, not all inadequacies can be addressed with a systematic literature review, such as improper collection of mortality and serious events data that rely on a different process for review. It is always important to collaborate with your organization’s regulatory authorities or a regulatory specialist to make sure you are complying in these areas.
Following leading practices and presenting clinical data in a straight-forward manner helps manufacturers be in good position to help regulatory agencies not to have to say No to your CER submission. Lack of organization and transparency can create a cycle of generating responses to regulatory agencies and delays getting devices to market.
Systematic literature reviews can help you find gaps in information that may be needed for inclusion in the CER, as well as putting your best foot forward by strongly providing sufficient clinical evidence for the evaluation of safety and performance of the device. Regulatory agencies expect this level of compliance. We can help you meet the challenge. We are experts in this area. Check out our recent webinars to better understand the process.
Systematic Literature Review to Help Meet MDR Requirements
Systematic Literature Review to Empower Data-Driven Decision-Making
At Criterion Edge, we are experts at generating methodologically sound systematic literature reviews and state-of-the-art reports to ensure your CER is ready for review by notified bodies. And, we can help ensure the scientific validity is adequate and document the methods we use for data collection. Talk to us about running a systematic literature review for you.