July 8, 2016
Clinical Evaluation – A continuous process
Likely one of the most challenging requirements in the upcoming European Medical Device Regulation (MDR) and European IVD Regulation (IVDR) is the need to perform a clinical evaluation regarding safety and performance, including post-market clinical follow-up, throughout the whole life-cycle of the product and regardless of the device’s classification. In the new regulations, the clinical evaluation is considered an essential part of the product’s Technical File and absence may limit the route to market access, or even withdraw current marketing certifications. Already Notified Bodies are expecting up to date clinical evaluation reports (CERs) with extensive data review according to the applicable guidelines and performed by qualified reviewers. More and more we see questions of Notified Bodies on missing or low quality CERs leading to delayed or discontinuation of CE-certification.
The requirement to conduct a clinical evaluation on your medical product is not unexpected. Several medical device scandals (e.g. PIP breast implants, metal-on-metal hip implants, pelvic meshes) show how users have been put into serious risks using their market-available medical device. Adequate clinical evaluation of the devices before or during the market access period could have led to early warnings, thereby avoiding or reducing the impact of the risks tremendously. Currently, Notified Bodies receive only limited information during their review process, i.e. the presentation of individual reports of (pre-)clinical data – without having all data being put together to draw one overall conclusion, without reassurance that no data is withheld from review, and without any product experience data available.
The CER is considered a tool to provide Notified Bodies with a complete overview of the continuous clinical evidence of safety and performance of the medical device. Or, as the philosopher Aristotle told us: “The whole is greater than the sum of its parts”. During the clinical evaluation process, all data that could provide information on the clinical safety and performance of the device is analyzed and assessed. This may include pre-clinical study data, clinical study data of the evaluated product, and/or clinical study data from equivalent devices identified through a systematic literature review. Mind that part of this data may already be part of your Technical File. However, recent (post-market) data should continuously be included and compared with your existing knowledge and available risk/benefit assessment. The full process of the clinical evaluation is then documented in one CER and, as stated before, becomes an integral part of the product’s technical documentation.
In line with this new requirement also MEDDEV 2.7/1, providing guidance on the clinical evaluation process, has thoroughly been revised. The extend of the revision is a clear representation of the urgency defined in the upcoming MDR and IVDR – almost a complete new document is written, with detailed information on requirements regarding evaluation timelines, evaluation skills and data assessment. This guidance is therefore considered an important tool, both for manufacturers and Notified Bodies, in the clinical evaluation process and detailed knowledge is essential.
Recommendation: Time will learn what the effects of the new regulations and revised guidance will be on the safety of medical products in Europe; whether scandals can be avoided or whether intended misconduct will continue to be a topic of investigation. However, it is important to realize that the Notified Bodies are taking the clinical evaluation of medical products very seriously – and so should manufacturers. The evaluation of a product is not a one-moment-in-time shot, but a continuous process, providing an unlimited amount of information on your medical device.
By Anne Leijsen