Get a copy of the slides from this webinar or click to watch the recording.
In this second part of our 2-part webinar series, Criterion Edge will continue to present strategies for assessing key components of your CER for possible misalignment with key EU MDR requirements. Presented from the perspective of seasoned regulatory writers with deep experience authoring MedDev rev. 4 and MDR-compliant CERs, this practical presentation will help you assess your document through the critical lens of a writer and identify possible gaps for mitigation before prior to submission to regulatory authorities. In this series, we will examine the Clinical Data Sources, Equivalence, and Risk/Benefit Analysis Profile sections of the CER.
In the first webinar of this series, we discussed the State of the Art, Safety & Performance Criteria, Equivalence, and Systematic Literature Review.
Click here to get the slides and watch the recording for part 1.
Key Takeaways:
• Understand the key components of a clinical evaluation report (1-min review of last webinar, clinical evidence, SLR, risk benefit, conclusion – have you ensured that your conclusion reflects conclusions from other sections/data?)
• Determine how to evaluate your CER for key requirements of the MDR
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.
Click here to watch the recording.
We had such a large turnout at our previous webinar, How to Assess Your CER for MDR Readiness, Part 1, and left with some questions unanswered. Therefore, President Laurie Mitchell held a live Q&A to respond to questions regarding CER for MDR Readiness. In this webinar, Laurie delves deeper into some of your pressing questions like:
- Would you recommend using clinical data from systematic reviews and meta-analyses to support the safety and performance of the subject device?
- Do you compare warnings and precautions as part of clinical equivalence?
- Can you give an example of a safety/performance objective and corresponding acceptance criteria?
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
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.