Following its open letter to the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council of the EU and to the EU Commissioner for Health, Vytenis Andriukaitis, EAP has received a reply from Commissioner Andriukaitis’s cabinet.
In the document, EU Commissioner Andriukaitis’s Head of Cabinet, Mr. Arūnas Vinčiūnas, thanked EAP for sharing its concerns on the need to tackle tuberculosis, antimicrobial resistance (AMR) and the lack of vaccine confidence, as well as the impact of the EU Paediatrics Regulation and the areas it still needs to address.
Likewise, it pointed out future EU actions and initiatives devised to address the aforementioned issues, among which:
The Cabinet of EU Commissioner Andriukaitis also thanked EAP for offering to share its knowledge and on antimicrobial stewardship (AMS) in order to “support training on AMR and AMS”.
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.
