In the third and final webinar of the series with Ronald Boumans, senior consultant for regulatory affairs at Emergo by UL we learned on the importance of Summary of Safety and Clinical Performance (SSCP) guidelines. SSCP is a critical component of the European Medical Device Regulation (MDR).
The SSCP is a new addition to the MDR. Article 32 of the MDR lays out requirements for creating SSCPs for all implantable medical devices. The purpose of the SSCP is for both patients and users to grasp the protocols for safety and performance of implantable Class III devices. You can review guidance in Medical Device Coordination Group (MDCG) document 2019-9.
So, when is the SSCP required?
The SSCP is required for all Class III devices, all implantable devices, and all Annex XVI devices.
If my device isn't categorized as any of the above, am I in the clear?
You don’t need to worry about the SSCP initially if your device:
- Is a custom-made device.
- Is an investigational device.
- Is utilized for a clinical evaluation consultation procedure and scrutiny procedures.
What steps should I take to ensure that SSCP meets the expected specifications?
To make sure your documentation meets these requirements, you must submit a draft of the SSCP for review and then approval by a Notified Body. Once the SSCP is approved, Notified Body will upload the document to Eudamed. The manufacturer must state on the label the instructions for using the product where the SSCP is available. For devices that fall under the scrutiny of Article 55 of the MDR, the SSCP must be included in the documents to be submitted by the Notified Body.
Is all of this really necessary?
While this may feel like a lot of excess work to ensure you are staying compliant, it is important to remember that the SSCP is just a summary. In the summary, there must be a Clinical Evaluation Report (CER), Periodic Safety Update Report (PSUR), and the evaluation report for post-market clinical follow-up (PMCF). All the data in the SSCP must be covered by technical documentation.
What is the process for getting my SSCP approved and how often do I need to review it?
Timing is an important factor when considering the SSCP. It is essential to remember that the Notified Body has to validate the SSCP. You will want to update your SSCP annually then have it reviewed by the Notified Body. Always make sure that your documents are synchronized and consistent.
What content should be included in the SSCP?
First, ensure you are including general information about the device and how to identify it. The next step is to give background as to the device’s intended use. Include a description of the device, risks, warnings, and some suggestions about training for users. Above all, remember that the SSCP is not intended to replace the instructions for use of your device.
The SSCP should be "written in a way that is clear to the intended user and to the patients."
So often, we are writing for our peers and medical professionals. Remember to consider readers of all educational levels. Physicians want to have a complete understanding of the risks and benefits of your device, and patients want to understand device complications, uses, and risks.
Assume patients do not have any medical expertise. To meet the needs of all users, be sure to include lay language. For example,
- Patients may not understand the word "subjects." Instead, one could use "people taking part in a study."
- Avoid medical terms such as "the porcine valve was found non-interior to..." Instead, try, "the heart valve from a pig's heart was found to be as good as...."
Above all, ensure that the translation is done properly to ensure that all member states can actually use the device. Additionally, an English translation is always required. The Notified Body will review the translations, which will then be specified through technical documentation as well as Eudamed. Make sure to write in a clear way so that the patient can really understand the device. We recommend partnering with a language expert to get this done.
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