The European Commission has adopted a new Delegated Regulation expanding the list of implantable and Class III medical devices recognised as well-established technologies (WET).
Devices on this list may be exempt from the requirement to conduct a new clinical investigation, provided sufficient clinical data are available. Importantly for paediatric care, the expanded list includes many commonly used devices such as cannulas, feeding tubes, gastrostomy buttons, ventricular drains, guidewires, shunts and embolisation coils, among others.
While not all relevant paediatric devices are yet included, this represents an encouraging step towards reducing unnecessary regulatory barriers and helping safeguard continued access to established technologies used in children’s care.
EAP will continue advocating for the needs of children to be fully reflected in European medical device policy.
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.
