What the MDR requires: Clinical evaluation of medical devices
What is important in the clinical evaluation according to MDR
The transition from the MDD to the MDR has significantly increased the effort required for the clinical evaluation of medical devices. For example, MDCG 2020-13 now explicitly asks whether multiple scientific publication databases were searched to avoid bias. This is intended to ensure that important information about the medical device—which may be found in only one database—is not overlooked. Consequently, it is no longer sufficient to search just one database, as was still possible under the MDD.
In addition, the “Essential Requirements” (ER under the MDD) have now become “General Safety and Performance Requirements” (GSPR). Here, too, it is important to list all GSPR relevant to the clinical evaluation and to demonstrate compliance using clinical and non-clinical data. The GSPR have introduced, among other things, additional requirements for the IT security of products—an area in which we at BAYOOSOFT support our customers with our many years of software expertise.
Equivalences: Requirements for an equivalent product
The requirements for a product to be considered equivalent have also increased significantly. For example, technical, biological, and clinical parameters must now be compared in detail and largely correspond with one another in order to establish equivalence. For medical software products, equivalence is required right down to the core of the software: the software algorithm.
This is where the difficulty lies, because manufacturers need access to the technical documentation for the equivalent product. With an in-house product, this is not a problem. However, equivalence is often claimed for competitors’ products, which in practice frequently fails due to a lack of insight into the technical documentation.
The “Performance and Safety Endpoints” of the clinical evaluation
The MDR has also made “performance and safety endpoints” more important. Manufacturers should by no means overlook these, as their absence will be conspicuous—at the very latest—in the Notified Body’s nonconformity report. What matters here are all relevant and traceable parameters based on the latest medical knowledge pertaining to the product.
In addition to searching multiple databases, the requirements for literature searches and evaluations have also increased. The search process must be clearly defined and transparent, as must the criteria used to evaluate the reviewed literature.
