Today GoINPHARMA™ meets Dr. Chris Rule, Manager Solutions Delivery at Maetrics.
An experienced regulatory and quality professional with an engineering background, Chris has gained a wealth of experience in the development of medical devices and the management of quality systems, particularly in the orthopaedic, neuro, ENT, vascular, surgical and wound care markets. In addition to CE marking, Chris has firsthand knowledge and experience of the stringent requirements demanded by the European and FDA regulatory requirements, including clinical evaluations and biological compatibility rationales.
GoINPHARMA™ : Chris you work as Manager Solutions Delivery at Maetrics, what does your company do and what has been the journey so far?
Chris Rule: Maetrics is a consulting firm exclusively focused on serving the Life Sciences sector. Founded in 1984, the company has evolved to become a global force supporting a significant number of pharmaceutical, biopharmaceutical and medical device firms with their most critical enterprise compliance, performance improvement, risk management, information technology and organisational change management initiatives. Maetrics is currently present in the US (5 offices), the UK and Switzerland.
GoINPHARMA™ : I would like now you to introduce the topic of Clinical Evaluation Report. What is the issue and why is it becoming more important?
Chris Rule: The Clinical Evaluation Report (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 Clinical Evaluation Report (CER) as part of its Technical File. However 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). In addition to this, scandals such as Poly Implant Prostheses’ 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 very much into the public eye. Notified Bodies (NBs) and their handling of CERs are therefore coming under increasing scrutiny, which will further intensify with the introduction of the new Medical Device Regulation (MDR).
Manufacturers of Medical Devices who sell their products within Europe must have a CER as part of their product Technical File. This is not a new requirement, but too many manufacturers believe that, as they have their CE Mark, they can rest assured that their CER passed the Notified Body documentation review. But Product Technical Files are not a static book; instead, Technical Files should be continually reviewed and updated.
GoINPHARMA™ : Chris, what next now, how can manufacturers ensure their CERs are always compliant and up to date?
Chris Rule: 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, there will be an increasingly important body of clinical evidence to 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. Within the first five years of a product being on the market, for example, numerous 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.
GoINPHARMA™ : What about CERs for medical devices that are not new and have been on the market for a number of years?
Chris Rule: The same process of updating and keeping information fresh 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.
In addition to this, CERs also need to work with Risk Management, Vigilance and Post Market Surveillance activities like an eco-system and not co-exist in individual siloes, as often happens. In our experience, the majority of medical device manufacturers urgently need to rethink how they maintain their CERs moving forward. Unfortunately, just because a CER was acceptable five years ago does not mean it will be acceptable now. 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 Medical Device Regulations (MDR) become effective
GoINPHARMA™ : What benefit is there to businesses in keeping their CERs updated?
Chris Rule: We are finding that even 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. This results in expensive and unexpected investment to correct CERs at the last minute. Notified Bodies are placing increased scrutiny on CERs and are rightly increasing their rigorous standards which, combined with advances in technology, data collection and medical innovation, makes the business case for viewing CERs as a key part of a product Technical File, especially where clinical data for the device is not present, extremely strong.
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