Summary of Safety and Clinical Performance
As part of the EU MDR, which aims to limit future issues by providing a more transparent and robust regulatory framework, manufacturers now have to write a summary of safety and clinical performance (SSCP) available for their Class III and implantable devices.
To provide further guidance on the presentation, content, and validation of the SSCP, the Medical Device Coordination Group (MDCG) published MDCG 2019-9. This goes into much more detail than the EU MDR and includes significant information intended to overcome difficulties physicians had due to device changes made without their knowledge, which potentially impacted patient care. In the end, the goal is to improve the health and safety of patients.
Healthcare professionals can also use the data from SSCPs to make more informed decisions about patient care, by providing them with an “objective and balanced summary” of the clinical data. Another benefit is that patients can do research more easily about the devices recommended by their healthcare providers, which allows them to learn more about the risks and undesirable effects and therefore make more informed decisions.
Creating a Compliant SSCP
An SSCP is an external document that includes information about a medical device, such as general information about the device, a summary of the clinical data for the device, and possible therapeutic alternatives.
You compile the SSCP data directly from the technical documentation, including the clinical evaluation report (CER) and periodic safety update report (PSUR). The SSCP is then submitted to the notified body with responsibilities to validate it. This includes verifying whether all relevant information in the technical documentation is reflected in the SSCP, and confirming that all the information in the SSCP is sourced from the technical documentation. After validation, the notified body will publish the SSCP in the Eudamed database.
Once complete, SSCPs are visible to healthcare professionals, patients, and competitors. They include a section written for professionals and, when relevant, a section written for patients. It must be clearly written to the intended user and fully understood by a patient with no medical expertise.
The SSCP must include sections that address:
- Identification of the device and the manufacturer, the basic UDI-DI, etc.
- Intended purpose, indications, contraindications, and target populations.
- Description of the device and its accessories.
- Information on any residual risks and any undesirable effects, warnings, and precautions.
- A summary of the clinical evaluation.
- Possible diagnostic or therapeutic alternatives.
- Suggested profile and training for users.
- Reference to any harmonised standards and common specifications applied.
- Revision history.
Practical Tips for a Compliant SSCP
FOLLOW THE GUIDANCE
Ensure the SSCP and technical documentation align and include all sections and relevant quantitative data outlined in the guidance. The notified body may also require a signature from the person responsible for regulatory compliance (PRRC). Manufacturers should treat the guidance as representing best practices.
CREATE AND MAINTAIN TEMPLATES
Create and maintain templates, as you should consistently present documentation. PMS, risk management, instructions for use, and clinical evaluation can create problems when writing the SSCP. You should update clinical evaluation templates to ensure that the information needed to complete the SSCP is easily available.
CLIN-r+ recommends using templates to share the same fundamental information across all technical documentation to ensure alignment.
SUMMARISE EFFECTIVELY
Although manufacturers and notified bodies may have different preferences regarding how much detail to include, there is a balance between providing too much and not enough. Your intent is to ensure they easily understand the information, and therefore too much detail can be confusing. However, too little information doesn’t fulfil the intent to be transparent. You should provide quantitative data in a high-level summary.
The more quantitative data you can provide about the benefits and risks of the device, how the patients will benefit from the device, and how it compares to other devices. The NB will ask fewer questions, so provide as much objective evidence as possible.
The SSCP must extract information from the technical documentation already existing. It’s much easier to write an SSCP if there is a well-written CER and IFU with a clear description of the device, intended use, indications for use, benefits, and residual risks in place. This will also make it much easier for the NB to validate the content in the SSCP.
USE PLAIN LANGUAGE
Although the SSCP is a regulatory document, the intended audiences are healthcare professionals and patients, so we should write it with minimal regulatory language. Ensure the summary clearly provides the evidence and complies with the regulations and guidance, but is also easily understandable by the intended audience.
CREATE ALIGNMENT
Although there is no specific guidance about who should compile and write the SSCP, it requires various inputs and needs to be reviewed by the appropriate individuals.
When possible, the person who writes the CER is typically the best person to write the first draft of the SSCP.
CLIN-r+ recommendations
CLIN-R+ has created hundreds of technical documentation files, including SSCPs and CERs. We have the knowledge, proven processes, and expertise to ensure success.
We have valuable experience preparing SSCPs for our clients. If you’re starting the process of creating your SSCPs, this post covers the basics and some lessons learned from our own experience.
To learn more about CLIN-r+ services for medical devices and IVD manufacturers, get in touch!
Clinical Evaluation for Medical Devices
Person Responsible for Regulatory Compliance (PRRC)
