The End of “Loopholes”
Successfully achieving MDR conformity – The Clinical Evaluation as a Challenge
With the introduction of the MDR, the requirements for the clinical evaluation have significantly increased, posing serious difficulties for many manufacturers. Therefore, an efficient but nevertheless focused clinical strategy is indispensable.
In short, everyone is in the same boat and must overcome similar barriers and uncertainties, regardless of the risk class of the medical device. Especially in the field of class III products, approval without an extensive clinical / PMCF study is almost no longer possible. Established “loopholes” such as the equivalence route are highly limited, various new requirements and documents in the clinical field cause inconsistencies. How does this affect practice?
- Clinical theory and practice of the MDR often diverge
- Early implementation of clinical aspects is underestimated
- Project cost explode due to lack of coordination with the notified body
- Insufficient clinical evidence for the general safety and performance requirements (GSPR) leads to significant delays in subsequent development planning
- Uncertainty regarding applicable laws, standards, and guidelines due to contradictory content
Experience and Expertise as a Key for the Successful Clinical Implementation
As is often the case in real life, practice makes perfect. From our own experience with class III devices, we have learned that no generalized strategy for a successful clinical strategy exists. Each medical device has its own challenges and history. For example, it makes a big difference whether innovative techniques are applied or whether the medical device is a legacy device that has been on the market for a long time. Through our own conformity and consulting projects in various areas, we have learned that early and coordinated planning can minimize errors. Our Clinical Affairs expert shared this experience in a presentation at MedConf in Munich.
Clinical Studies as an Opportunity and Companion for Life-Saving Medical Devices
Efficiency and cost reduction are often the main focus in the development of new medical devices. Conducting a clinical trial is usually associated with high costs and time-consuming implementation processes. Nevertheless, a successfully conducted study can ensure or even increase the efficiency and, above all, the safety of a medical device in the long term and should therefore not be regarded as an obstacle by default. Results from studies can be very effectively transferred to other medical devices, thereby accelerating the certification process. For example, studies regarding the safety and performance of a medical device can be easily transferred from a predecessor model to the successor model, thereby significantly and effectively increasing the impact of clinical evidence. Comparable software solutions, such as the architecture of an embedded algorithm, are likewise common. It is worth taking a closer look to ensure that you are not missing the potential use of existing data.
Although the transition from MDD to MDR is a major challenge from the clinical perspective, it is also an opportunity to improve the safety and performance of medical devices.