Euro Convergence: SSCP expert lists common mistakes device manufacturers make
AMSTERDAM – Some of the most common mistakes manufacturers make when complying with safety and clinical performance (SSCP) requirements may sound simple enough to fix, but such issues tend to be persistent, said Rachel Gibbs, principal regulatory consultant at NAMSA, during this year’s RAPS Euro Convergence meeting in Amsterdam.Beyond her current role at NAMSA, where she advises companies on how to comply with notified body requirements, Gibbs also has experience as an auditor for the British Standards Institution (BSI).
“The purpose obviously of an SSCP is transparency … providing clinicians with the information to make the appropriate clinical decisions and providing patients with that information so they can make informed decisions on whether they want to pursue a certain treatment,” she said during an 11 May session on SSCP best practices.
Gibbs added that the SSCP is supposed to be reviewed and published to the European Union’s EUDAMED database by notified bodies, but manufacturers are also supposed to post them on their company website. They also need to ensure the information provided in the SSCP matches up with information available in other databases.
“SSCP's are covered by guidance document MDCG 2019 part 9 and if you're writing SSCPs, you really need to consult this document, because it basically covers the content of the SSCP [and] provides a template which you are expected to follow,” she advised.
Gibbs noted that notified body auditors are well-versed in the regulations and a company’s product and want to see consistency in the available information.
Based on her experience and conversations with notified bodies, Gibbs said she’s compiled a list of common mistakes made by repeat offenders.
They include:
- Failure to include photos of the medical devices;
- Including marketing materials in the SSCP;
- Failure to include all device model numbers;
- Clinical Evaluation Reports (CER), Information for Use (IFU) content and SSCP don’t match up;
- In the absence of a European database on medical devices (EUDAMED) entry, there’s no link to the SSCP in the instructions for use (IFU) content on the manufacturer’s website; and
- Missing information listed with the Medical Device Coordination Group (MDCG).
Other issues Gibbs mentioned with SSCPs are that manufacturers often fail to include information on the frequency of risks or don’t detail them in relation to the product’s lifecycle.
“If you're a patient or a clinician you want to not only know how common is the side-effect, but are you going to see it immediately, or is it something you see in a week or three months’ time,” said Gibbs.
She noted that another problem is that manufacturers sometimes fail to include certain information related to clinical data as required by Medical Device Coordination Group (MDCG) guidelines, such as a summary of the data. Other issues include when clinical data presented within the SSCP is not discussed in the CER and failure to provide clinical results in the SSCP that may be unfavorable to the product, but are necessary to fully understanding the device performance.
As required by the regulations, manufacturers will provide a list of articles about the performance and safety of their device, but then fail to include any discussion about the significance of those articles according to Gibbs.
"Now obviously this is publicly available [information] and you can see why the manufacturer didn't want to put this in, but the auditor has read the CER, so the auditor actually already knows what data should be there really,” Gibbs said. “So, it's quite apparent when something like that gets missed.”
Other common considerations manufacturers often fail to include in their SSCP summary include list of harmonized standards their device complies with and data on alternative treatments.
Gibbs said that manufacturers are often docked for not providing benefit-risk assessments of therapeutic alternative treatments. This is especially important when there are no indications when an alternative treatment may be better particularly when dealing with vulnerable populations or in other situations when the manufacturers product isn’t suitable.
