Cardiologists lead charge for medical device approvals in Europe to be more rigorous
CE mark approval in Europe is often compared to U.S. Food and Drug Administration (FDA) approval in the United States, but the bar is actually much lower for getting a device approved in Europe. That is because something only needs to show safety combined with minimal efficacy to gain approval in Europe.
However, there is potential for that to all change in the near future.
The CORE-MD (Coordinating Research and Evidence for high-risk Medical Devices) consortium this week published new consensus recommendations in The Lancet Regional Health Europe that call for much more scientifically robust methodologies for clinical investigations of high-risk medical devices.[1] The recommendations were also submitted to European Union regulators for consideration in future guidance on medical device clinical evaluation.
These recommendations are responding directly to a request from the European Commission to provide expert advice on trial design to address a longstanding gap in guidance for the evaluation of high-risk technologies. These types of devices include cardiovascular implants, orthopedic implants, and diagnostic systems for managing diabetes.
Unlike drugs, which must demonstrate safety and efficacy before market entry, high-risk medical devices in Europe are required to provide only “sufficient clinical evidence,” explained the European Society of Cardiology (ESC) in a statement on the CORE-MD recommendations. The ESC said this standard that is not well defined and open to wide interpretation. The CORE-MD analyses confirms that many devices have entered the market without robust evidence from randomized trials, and products often gain CE mark approval with little or no data in the public domain.
“These recommendations provide a clear scientific foundation for the evaluation of high-risk medical devices in Europe. Unlike the European Medicines Agency or the U.S. Food and Drug Administration, which utilize regulatory science, the EU framework has relied in the past on legal interpretation rather than clinical principles. By setting out a hierarchy of methodologies, we can now help developers, regulators and clinicians implement strategies that deliver robust, transparent, and patient-relevant evidence,” Professor Alan Fraser, coordinator of the CORE-MD project, explained in an ESC statement. He is also a former president of the European Association of Cardiovascular Imaging and former chairman of the ESC Committee on Regulatory Affairs.
CORE-MD said the central challenge will be ensuring the implementation of the new rules within the EU Medical Device Regulation framework to safeguard patient safety, while supporting medical innovation.
“The European Society of Cardiology welcomes these new recommendations from the CORE-MD Consortium on the design and requirements for clinical investigations of high-risk medical devices in Europe," ESC President Professor Thomas Lüscher, director of research, education and development with Guy's and St. Thomas' Hospital, said in a statement. "Convincing data on the efficacy and safety of new devices, ideally based on randomized clinical trials, are crucial for their use in patients with heart disease."
Lüscher said trials of devices for high blood pressure using sham controls can be very insightful. Surveillance of devices also provides important information during clinical follow-up, so it is a major strategy of the ESC through its international registries such as GRASP and EuroHeart.
Key regulatory recommendations from CORE-MD
CORE-MD recommended a four-stage framework for clinical investigations, from initial studies to long-term follow-up. It called for greater use of randomized controlled trials, including sham-controlled trials with appropriate ethical safeguards. Efficient large-scale trials can also be embedded into registries to accelerate evidence generation. The group also called for the mandatory transparency of study design, protocols and results.
In addition, CORE-MD called for tailored approaches for breakthrough or orphan devices for rare conditions, or where there are no other treatments. These devices should require post-market confirmatory studies.
These are all benchmarks already used in the FDA's review process. This helps explain why U.S. regulatory clearance takes much longer than in it does in Europe.
The CORE-MD consortium is funded by the EU Horizon 2020 program and led by the ESC with the Federation of National Societies of Orthopaedics and Traumatology (EFORT). The effort brought together 100 leading academic trialists, clinicians, regulators, patients and health technology assessment experts across Europe. Its findings have already informed proposals for reform of the EU regulatory system from the Biomedical Alliance in Europe, representing 35 medical societies.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]