There is a balance to be struck around the regulation of medical devices between promoting innovation and availability, while ensuring safety and reliability.
The headline from the recent conference on medical devices and patient safety was that there is now high-level acceptance that the EU Medical Devices Regulation (MDR) of 2017 didn’t get this balance right. Attended by stakeholders from across the health sector, regulatory bodies and industry, there were plenty of stories illustrating the adverse impact of the MDR on device availability, especially for smaller patient groups and rare diseases (which of course impacts paediatrics). Small to medium size manufacturers could no longer sustain the pipeline of relatively rarely used devices, even if lifesaving for small numbers of patients.
The second headline is that the European Commission are determined to reform the regulations to address the issues, and keen to have stakeholder input in the process. The proposed reforms aim to simplify and reduce the regulatory burden, without compromising safety, through a more proportionate, risk-based approach. Overall, there is much to commend them.
But in trying to provide a ‘fix’ across all of medicine, the worry is that they may still not work well for some aspects of paediatrics – will there be sufficient incentives and support for low-volume product lines, and will post-market surveillance work?; will there be shortcuts around paediatric evidence and expert scrutiny that compromise safety?; will inequity of access be inadvertently increased? The EAP Strategic Advisory Group on Medicines and Devices aims to gather evidence and to feed into the process.
Do get in touch if you want to be involved.
New ways to test high-risk medical devices.
Manufacturers of medical devices need to test their products before being allowed to market them. Specifically, they require clinical data showing their medical device is safe and efficient. In this context, the EU-funded CORE-MD project will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators. The project will propose how new trial designs can contribute and suggest ways to aggregate real-world data from medical device registries.
It will also conduct multidisciplinary workshops to propose a hierarchy of levels of evidence from clinical investigations, as well as educational and training objectives for all stakeholders, to build expertise in regulatory science in Europe. CORE–MD will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators, to achieve an appropriate balance between innovation, safety, and effectiveness. A unique collaboration between medical associations, regulatory agencies, notified bodies, academic institutions, patients’ groups, and health technology assessment agencies, will systematically review methodologies for the clinical investigation of high-risk medical devices, recommend how new trial designs can contribute, and advise on methods for aggregating real-world data from medical device registries with experience from clinical practice The consortium is led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, and involves all 33 specialist medical associations that are members of the Biomedical Alliance in Europe.
