The Clinical Evaluation Report (CER) has come increasingly into the spotlight in the Medical Device regulatory world. In fact, every Medical Device sold into Europe, irrespective of its classification, must have an up-to-date Clinical Evaluation Report (CER) as part of its Technical File. Failing to provide an updated CER can result in Notified Bodies (NB) requesting that files are remediated which can be an expensive and time consuming process. Businesses wanting to achieve compliance are therefore increasingly focusing on ensuring that their CERs are inspection-ready.
More recently, scandals such as Poly Implant Prostheses’ use of cheaper, industrial-grade silicone in breast implants and toxic debris from metal-on-metal (MoM) hip implants causing cases of Metallosis, have cast the issue of Medical Device compliance very much into the public eye and increased scrutiny on the process with which NBs handle CERs. NBs are therefore scrutinising CERs more closely than before to protect Patient Safety and, where before CERs were previously just one element of a product’s Technical File, they have now become one of the most important sections.
Historically, however, guidance on CERs and more specifically around the clinical data they require has been very unclear and not comprehensive enough. When the 2007 amendment to the Medical Device Directive (MDD) came into force it managed to only partly shed light on grey areas. With the introduction of the new Medical Device Regulation (MDR), manufacturers and NBs should expect even higher levels of scrutiny.
Although all manufacturers of Medical Devices selling their products within Europe must already have a CER as part of their product Technical File, too many manufacturers still believe that, as they have a CE Mark, they have passed their Notified Body documentation review. Product Technical Files, however, are not static and should be regularly updated.
CERs are in fact initially usually based on literature reviews of equivalent products, components and compounds. After a few years in the market, however, there will be an increasingly important body of clinical evidence to support the product as well as Post Market Surveillance data that should be included in the CER. Risk management activities will have taken place and these too should feed into the CER. It is therefore understandable that for new products, NBs will expect to see the CER being regularly updated as new information becomes available.
The same process of updating and keeping information fresh obviously also applies to devices that have been in the market for many years and are not ‘new’ products. Advances in technology, data collection and medical innovation all result in more improved knowledge, understanding and data on device performance.
We are seeing that CERs that may have ‘passed’ a Notified Body review five years ago – even for devices for which advancements in technology, data collection and medical innovation have had little impact – are becoming more and more likely to receive recommendations for improvement and non-conformities. This is because Notified Bodies have come under increasing public pressure over the PIP prosthese and metal-on-metal implants scandals and are placing increased scrutiny on CERs.
Medical Device manufacturers urgently need to rethink their attitude towards how they maintain and update their CERs in light of new regulations and changing market pressures. Unfortunately, just because a CER passed scrutiny once, does not mean it will be acceptable again. If they aren’t already planning to do so, manufacturers should schedule a full review of their product CERs and get them in line with today’s expectations to protect themselves from having to engage in unexpected reparatory measures such as meeting recommendations for improvement and amending non-conformities.
By Chris Rule, Manager, Solutions Delivery at Maetrics