ERA is a member of the Biomedical Alliance in Europe (BioMed Alliance) .
The BioMed Alliance, of which ERA is a member, is raising awareness of the possible consequences of a poor IVDR implementation. The date of application of the new EU Regulation for In Vitro Diagnostic Medical Devices (IVDR) is only one year away, and the BioMed Alliance healthcare diagnostic providers are seriously concerned about the status of implementation of the IVDR. To date, many critical regulatory elements are not in place and important guidance is still lacking, making it extremely difficult for the EU diagnostic sector to be fully prepared in time for May 2022 and thereby threatening to affect patients’ lives across Europe.
The enclosed statement entitled: “Implementation of the new EU Regulation for In Vitro Diagnostic Medical Devices: a ticking bomb for the diagnostic sector” clarifies the hard stop that the diagnostic sector will face for conventional CE-IVDs if we do not collectively stand up now. In addition, clear and appropriate guidance is needed for in-house devices, also known as laboratory developed tests (LDTs), in order to help laboratories to prepare in time for the new legislation and to support the development of innovative solutions for niche applications, rare diseases and rapid responses to health crises.
The diagnostic sector will be transformed by the new regulation and it is our responsibility to ensure a proper implementation of the IVDR.
The BiomedAlliance celebrates 10 years of existence
Watch the video created for the BiomedAlliance General Assembly where 10 years of commitment to improve health and biomedical research in Europe is celebrated.
New BioMed Alliance Statement: Open Access Initiatives must not create inequality
Together with medical societies from the Open Access Transition Working Group of the BioMed Alliance we published a statement on 5 October highlighting a series of concerns around Plan S. The statement also expresses support for a European Research Council statement from 20 July stating the ERC’s concerns around this open access initiative and announcing their withdrawal from cOAlition S.
Our main concerns regarding Plan S are focussed on the consequences for: researchers (including inequality and rising costs), guaranteeing the quality of research (especially in health research) and hybrid journals (which play an essential role in informing health care professionals through medical society publications).
The Biomedical Alliance in Europe (BioMed Alliance) is a non-profit organisation representing 31 leading European research and medical societies uniting more than 400,000 researchers and healthcare professionals.
The BioMed Alliance is committed to promoting excellence and innovation in the European healthcare field with the goal of improving the health and well-being of all European citizens
It promotes the interests of researchers and healthcare professionals organised in not-for-profit scientific medical associations and organisations, across all medical disciplines.
The BioMed Alliance has developed the Code of Conduct for healthcare professionals and scientific organisations, approved by all members. The BioMed Alliance Code of Conduct sets out core principles to maintain and enhance professional independence, objectivity and scientific integrity.
The BioMed Alliance has addressed important issues for biomedical and health research in the EU such as: the EU Data Protection Regulation, clinical trials, the implementation of Medical Devices Regulation, EU research budget, ambitious mechanisms to boost health research, and certain European Citizens’ Initiatives that could hamper research.
The BioMed Alliance has achieved recognition and strength in negotiations at EU level. We advocated for the creation of a Scientific Panel for Health (SPH) under Horizon2020. The SPH is a science-led stakeholder platform aimed at providing a science-focussed analysis of research and innovation, identifying bottlenecks as well as opportunities, and making strategic recommendations.
The BioMed Alliance has been promoting the development of unbiased criteria on continuous medical education. In addition, it has been providing expertise on the EU regulatory framework, particularly in relation to medical devices.