Dr Isabell Lang-Zwosta, Dr Knoell Consult, discusses clinical evaluation reports and the challenges and consequences for the medical device industry.
Dr Isabell Lang-Zwosta
Dr Isabell Lang-Zwosta, Dr Knoell Consult
From the perspective of the European Commission, the ‘new’ medical device regulation (MDR 2017/745) should ensure that medical devices are ‘safe and of high quality. This might only be achieved by strengthening the rules on placing devices on the market and tightening surveillance once they are available’. Having set this noble goal, a broad range of changes in the medical device industry is ahead.
One of the major topics manufacturers of medical devices are struggling with is the compliance with the requirements for clinical evaluations. Taking together the requirements laid down in the MEDDEV 2.7/1 Rev. 4 and the MDR it becomes obvious that submitting a clinical evaluation report containing the expert opinion of medical doctors in regard to the performance and safety of the device is no longer deemed appropriate; not even for low risk and grandfathered devices!
Therefore, if you are planning to bring your medical devices to the European market, you need to implement a “systematic and planned process to continuously generate, analyse and assess the clinical data pertaining to your devices (not an equivalent device) in order to verify the safety and performance, including clinical benefits of the device when used as intended by the manufacturer.”
But what does clinical data mean? It is data that concerns the safety or performance of the device and may be sourced from published clinical literature, in-house (unpublished) clinical reports and data, clinical trials, post-market feedback and clinical experience, external post-market data such as registries or post-market databases (i.e. FDA’s MAUDE).
Nevertheless, be cautious when basing your clinical evaluation on literature data only. The rules became more precise and stricter. Times of cherry-picking of the favourable literature only without pre-defined search strategies are over. The literature review plan (eg. as part of the mandatory clinical evaluation plan) for your device needs at least to outline and justify the choice of search databases, search terms as well as inclusion and exclusion criteria. In addition to that, the evaluation strategy for literature identified within this process should be described and duly justified.
Following the literature search and the appraisal of clinical data from any source, all information on your device needs to be analysed in order to demonstrate compliance with all of the essential requirements pertaining to the safety and performance of your device when used as intended. This analysis of literature and clinical data does also describe the benefits and risk of the device and explains the acceptability of the risk/benefit ratio taking into account the ‘state of the art’ treatment.
Within this process, the expertise of the author(s) plays an important role. It is not only the product knowledge OR the clinical expertise that counts. The notified bodies put special emphasis on the combination of knowledge of the product, the regulatory requirements, biostatistics, medical writing, diagnosis and management of the disease to be treated (including treatment options) and research methodology. This might not be found in one person, only but in terms of the clinical evaluation a joint project could be set up. That way you have your internal (or external) key players on board to guarantee consistency between your clinical data, the instructions for use and the risk management documentation in order to identify gaps and discrepancies, residual risks and uncertainties or unanswered questions that should be addressed within your post-market surveillance plan.
The initial clinical evaluation report is just the beginning of the story. Since it is to be seen as a continuous process during the lifecycle of your device you better make it a living process in order to meet the noble goal of the European Commission: “Safe devices of high quality”.