The Clinical Evaluation Report (CER) is becoming an increasingly-important issue among medical device manufacturers. In fact, although every medical device sold into Europe must have an updated CER as part of its Technical File, a number of scandals such as PIP’s use of cheaper, industrial-grade silicone in breast implants and toxic debris from metal-on-metal hip implants, have put the CER under growing scrutiny.
CERs, previously just seen as one element of a product’s Technical File, have now become one of the most-important sections
Notified Bodies (NBs) are examining CERs more closely than ever before to protect patient safety, and CERs, previously just seen as one element of a product’s Technical File, have now become one of the most-important sections.
In particular, manufacturers remain confused around the topic of clinical data, in spite of the 2007 amendment to the Medical Device Directive (MDD). When the new Medical Device Regulations (MDR) officially come into force, the issue will become even more pressing.
Initial CERs are often based on literature reviews of equivalent products, components and compounds. Specifically, when a device is brand new, clinical evidence is often not available, but after a few years in the market an increasingly-large body of clinical evidence to support the product will become available. It is critical that this is included in the CER. Similarly, Post Market Surveillance data, and information from risk management activities, must also be included. NBs will expect to see the CER being regularly updated as new information becomes available.
A growing number of manufacturers that do have some processes in place to update their files, are finding that their CERs still do not hold up to more-exacting scrutiny and are out of date
Recently there has been an upsurge in instances of NBs inspecting product Technical Files and requiring that medical device manufacturers remediate their files. In addition to this, a growing number of manufacturers that do have some processes in place to update their files, are finding that their CERs still do not hold up to more-exacting scrutiny and are out of date.
But it’s not just new products that risk being caught out; the same process of updating and keeping information fresh also applies to devices that have been in the market for a number of years. Advances in technology, data collection, and medical innovation all result in improved knowledge, understanding and data on device performance. In addition to this, data derived from risk management, vigilance, and post market surveillance activities should also feed into a best-practice CER. Too many manufacturers may believe that they are safe, as they have passed scrutiny once they are fully compliant, but product Technical Files are dynamic and need to be regularly reviewed and updated.
In order to face the introduction of new regulation without concerns, medical device manufacturers need to urgently address how frequently, and with what data, they update their CERs
NBs are placing greater emphasis on CERs and even those that may have ‘passed’ a review five years ago – even for devices for which advancements in technology, data collection and medical innovation have had little impact – are more and more likely to receive recommendations for improvement and non-conformities. In order to face the introduction of new regulation without concerns, medical device manufacturers need to urgently address how frequently, and with what data, they update their CERs.