Clinical evaluation is arguably one of the most important topics in the international medical device arena and the EU is no exception. As the EU regulations continue to be rolled out, albeit with a sliding timeline, industry and notified bodies are focusing on the interpretation and implementation of clinical information as it supports the end goal of compliance. Notably, a planned revision of MEDDEV 2.7/1 over the next year will aid in bringing alignment with the EU MDR.
The first phase is expected to not only bring more explanation on how to conduct clinical evaluations, but how data from various types of clinical investigations can be used. Of these are retrospective studies, which are currently a focus of notified bodies who are reviewing a large amount of data to bolster what was previously required under the new approach directives (e.g., MDD). Updates in this round are also expected to be made to the terms not presently in Article 2 of the MDR, which will provide clarity with respect to clinical compliance.
In the second phase, changes are expected to be made to provide clarity to the information provided in EU MDR Article 61(10) when clinical data would not be sufficient to satisfy the EU MDR general safety and performance requirements (GSPR). This will help to bring device manufacturers and notified bodies to a common interpretation. Additionally, notified bodies are faced with a new challenge with needing to assess devices that contain artificial intelligence (AI). Establishing the clinical data requirements for AI, particularly for accuracy in identifying patient populations, without affecting additional exposure to unforeseen risks is daunting.
In the Spring of 2021, CORE-MD was launched. This Coordinating Research and Evidence for Medical Devices consortium is comprised of medical professionals, notified bodies, academic institutions, manufacturers, health authorities, and regulators. Within a rapidly changing environment including new innovations, the consortium is hoping to find new ways to continue to ensure public safety by assessing current methodologies for clinical evaluation of high-risk devices. The study will be concluded in 2024 and results are expected to be incorporated into the revision of MEDDEV 2.7/1.
Growing concerns in the medical industry have been heard by both the EU Commission and the Medical Device Coordination Group (MDCG), particularly with respect to the potential lack of devices for the treatment of rare diseases. Manufacturers are feeling the pressure of increased regulatory burden brought on by the requirements of the EU MDR and their potential loss of revenue, which has led many to pull their products from the EU market. Another issue that could affect the availability of devices on the market involves the potential for product equivalency. If a manufacturer wants to claim equivalence to another’s device, and in turn hopes to circumvent some of the requirements such as clinical investigations, there must be a contract between the two organizations by which the manufacturer seeking equivalency would be granted access to the technical documentation maintained by the original manufacturer. Since most manufacturers are unwilling to share such private and confidential information, the rate of equivalency has been low, directly affecting device marketing. Manufactures that were claiming equivalency under the previous regulations (MDD) may also have significant issues with being able to transition to the new MDR requirements based on the need for Post Market Clinical Follow-up (PMCF) and thus, removing their products from the market.
