Ten steps for reviewing your Clinical Evaluation Reports

1. Be aware of the issue

CER is a hot topic in the medical device regulatory world. Every medical device sold into Europe, irrespective of its classification, must have an up-to-date CER as part of its Technical File. Guidance, specifically around clinical data, is unclear and not comprehensive enough, resulting in confusion that was only partly assuaged by the 2007 amendment to the Medical Device Directive (MDD).
 

2. Don’t overlook the CER

Scandals such as Poly Implant Prosthèses’ (PIP) use of cheaper, industrial-grade silicone in breast implants and toxic debris from metal-on-metal hip implants have cast the issue of medical device compliance into the public eye. Notified Bodies (NB) and their handling of CERs are coming under increasing scrutiny, which will further intensify with the introduction of the new Medical Device Regulation (MDR). NBs are therefore scrutinizing CERs more closely to protect patient safety, and where CERs were previously just one element of a product’s Technical File, they have now become one of the most important sections.
 

3. Don’t expect a one-time fix

Because medical devices sold within Europe must have a CER, manufacturers may believe that since the products have their CE Mark that their CER passed the NB documentation review. Not necessarily. Product Technical Files are not a static book; the content does not stand still. Technical Files should be reviewed and updated continually.
 

4. Keep standards high to avoid remediation

When NBs scrutinize product Technical Files, they often require medical device manufacturers to remediate their files. More recently, a growing number of medical device manufacturers maintain their files but are finding that their CERs do not hold up to scrutiny. Files are regarded as out of date or not up to standard by increasingly taxing NB evaluations. Medical device manufacturers may feel confused, especially when, from their perspective, the CER passed on a previous review.
 

5. Include new evidence

Initial CERs are often based on literature reviews of equivalent products, components, and compounds. Because the device is new, clinical evidence may not be available, but after a few years in the market, an increasingly important body of clinical evidence will support the product, and this needs to be included in the CER. Likewise, there will be post-market surveillance data that must be added into the CER.
 

6. Don’t forget risk management data

Within the first five years of product launch, numerous risk management activities will have taken place, and these should feed into the CER too. NBs will expect to see the CER for new products regularly updated as new information becomes available.
 

7. Keep it fresh

The same process of updating and keeping information fresh also applies to devices that have been in the market for many years. Advances in technology, data collection, and medical innovation all improve knowledge, understanding, and device performance data. Facts from 10, 20, or more years ago may be questionable now. For instance, imagine a clinical evaluation for cigarettes 80 years ago when they were deemed harmless. When it became apparent that cigarettes caused illness, a filter was added to reduce the risk of illness. At that point, there may have been data to support the use of the filter, but the long-term effects of smoking were still unknown.
 

8. Be prepared for added scrutiny

It is not all about updating CERs. CERs that passed a NB review five years ago – even for devices for which advancements in technology, data collection, and medical innovation have had little impact – are more likely to receive recommendations for improvement and non-conformities. NBs are placing increased scrutiny on CERs as they have come under increasing public pressure from PIP and metal-on-metal implants scandals. This, combined with advances in technology, data collection, and medical innovation, strengthens the business case for viewing CERs as key parts of product Technical Files, especially where clinical data for the device is not present.
 

9. Break with the silo-approach

CERs also need to work with risk management, vigilance, and post-market surveillance activities in an eco-system, not co-existing in individual silos, as often happens. In our experience, the majority of medical device manufacturers urgently need to rethink how they will maintain their CERs.
 

10. Start preparing now for the new MDR

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 before the new MDR regulations become effective.

Maetrics
www.maetrics.com

About the author: Chris Rule is manager, solutions delivery at Maetrics, a full service life sciences consulting firm. He can be reached at crule@maetrics.com or +44 (0)115.921.6200.