By Chris Rule, Solutions Delivery Manager, Maetrics
Clinical evaluation reports (CERs) are becoming a crucial topic in the medical device regulatory world. Every medical device sold into Europe, irrespective of its classification, needs an up-to-date CER as part of its product technical file. However, guidance — around clinical data in particular —remains unclear and incomplete, and the resulting confusion was only partially assuaged by the 2007 amendment to the Medical Device Directive (MDD).
In the last few years, the CER issue has been thrust into the public eye following scandals like Poly Implant Prostheses’ (PIP) use of cheaper, industrial-grade silicone in breast implants, concerns over the use of vaginal mesh implants, and toxic debris from metal-on-metal (MoM) hip implants. These scandals highlighted the lack of clinical data in CERs, and resulted in notified bodies (NBs) putting more intense scrutiny on CERs in the interest of patient safety.
Medical device manufacturers must be careful to keep up-to-date with ever-higher modern standards, even if their product already has a CE Mark. With the EU’s new medical device regulation (MDR) soon coming into play, the scrutiny surrounding CERs will only intensify. Whereas before CERs were just one element of a product’s technical file, they now have become one of the most vital areas. With that in mind, follow these eight steps to properly assemble the CER puzzle:
1. Keep standards high to ensure continual compliance — CERs are not a one-time-only fix. The requirement for every medical device being sold into Europe needing a CER is not new, so many manufacturers believe that, as their devices already have earned their CE Mark, the box has been ticked and they can rest on their laurels knowing that their CER has “passed” the notified body documentation review. However, manufacturers must remember that a product’s technical file is not static, and it must be regularly reviewed, maintained, and updated. Even if their CER has passed review, manufacturers must be aware that the technical file’s content cannot remain static.
2. Continually review, and regularly update — Product technical files should be continually reviewed and updated. In fact, when NBs scrutinise product technical files, they all too often require that medical device manufacturers remediate their files. Also, more recently, there has been a growing number of medical device manufacturers who maintain their files to an extent, only to find that their CERs do not hold up to scrutiny and are regarded as out-of-date, or not up to standard, by increasingly taxing notified body evaluations.
3. Embrace new evidence — Original CERs are frequently based on literature reviews of equivalent products, components, and compounds. However, clinical evidence or data may be unavailable, especially if a device is brand new. But, once a product has been in the marketplace for a few years and an increasingly large body of clinical evidence exists to support its safety and efficacy, it is essential to include this information in the CER. Likewise, postmarket surveillance must be added into the CER.
4. Feed in risk management data — During the first five years a product is available on the market, for example, a wide range of risk management activities will be carried out, and these too should be fed into the CER. Furthermore, it is understandable that, for new products, NBs will expect to see the CER continually updated as new information from all activities becomes available.
5. Renew with fresh content — The process of regularly updating your CER with fresh information also applies to devices that have been in the market for many years and are not ‘new’ products. Improved understanding of “big data” and medical device performance has been born of advances in technology, data collection, and medical innovation. For example, facts that were believed just a few years ago may now be questionable, in light of new information. Imagine what a clinical evaluation report for cigarettes looked like 80 years ago, when they were believed to be good for you. When it became apparent that cigarettes caused illness, a filter was added to reduce the risk. At that point, there may have been new data to support the use of the filter, but the long-term effects of smoking still remained unknown.
6. Be prepared for greater scrutiny from notified bodies — CERs that “passed” a notified body review five or more years ago are increasingly likely to receive recommendations for improvement and non-conformities — even medical devices for which advancements in technology, data collection, and medical innovation have had little impact. This is because NBs are placing greater emphasis on CERs in the wake of the PIP Prostheses and MoM implants scandals. Accordingly, NBs are tightening their already rigorous standards and applying them with increased scrutiny. Combined with technological advances, this strengthens the business case for viewing CERs as a key element of a product technical file, especially where clinical data for the particular device is unavailable.
7. Break with the silo-approach by integrating activities — CERs must integrate and work with risk management, vigilance, and postmarket surveillance activities, combining to form an eco-system, rather than co-existing in individual silos. In our experience, most medical device manufacturers urgently need to rethink how they maintain and update their CERs. As has been mentioned, just because a CER was acceptable five years ago does not mean it will be acceptable now.
8. Start getting ready for the new Medical Device Regulations (MDRs) — If manufacturers have not already planned/conducted a full review of their product CERs, they need to immediately re-address their processes to ensure those CERs are in line with today’s high expectations, before the new MDR is implemented.
About The Author
Chris Rule is an experienced regulatory and quality professional with an engineering background. As the clinical evaluation lead and subject matter expert, he brings a hands-on approach and strong interest in new and evolving technologies to Maetrics clients. Together with his team, Chris has produced a white paper on the changing landscape of CERs. Download the CER white paper for free here.