Brussels, 13th March 2015 – The joint European Forum for Good Clinical Practice (EFGCP) and MedTech Europe Working Party announced today the launch of its Workshop Report and resulting “Roadmap for Medical Device Development in Europe.” This initiative is aimed at answering the question, "what constitutes - ‘high quality’ of clinical evidence for medical technology," in particular from an ethical, patient, clinical and regulatory perspective.
While medical technology is all around us, the science and knowledge around gathering the necessary clinical evidence for medical technology are relatively young.
This combined with the swift pace of advancements in medicine due to medical technology – witness the explosion in medical apps – means that a real knowledge gap exists. In a Report from a strategy setting Workshop in December 2014 and a solution-oriented Workshop Programme for May 2015 announced today, this new inclusive multi-stakeholder EU platform aims to set the record straight and be the defining voice of ethics and quality of clinical evidence for medical technology.
EFGCP together with MedTech Europe have established a joint Medical Technology Working Party which is open to all stakeholders including patients, researchers, academia, healthcare professionals, standards bodies, notified bodies, national and European authorities and industry.
Announcing the Report and Workshop Programme EFGCP Chairman Ingrid Klingmann said “We are happy to announce that the kick-off of this Roadmap initiative will be focusing on in vitro diagnostics, companion diagnostics and healthcare applications. We will then move on to other important topics such as ethics, quality, methodologies and risk management.” She added, “A constructive and energetic year is planned, to make sure the medical technology sector has its own spotlight and that concrete solutions are found for the well-being of patients.”
The Working Party initially organised a joint workshop on ‘Mitigating Risks in the Lifecycle of Medical Devices: Options and Challenges in Building Clinical Evidence’. The workshop, held on 4th December in Brussels, brought together patients, national competent authorities, ethics committees, lab technicians, healthcare professionals, industry representatives and European regulatory authorities with the aim of finding consensus on key topics of interest and potential policy recommendations, which could be taken forward in the upcoming revision of the Medical Devices Directives in Europe.
John Brennan from MedTech Europe noted “Setting effective ethical and quality clinical standards for medical technology is critical to ensuring that patients have access to safe and effective treatment. There is a lot to be discussed about what constitutes clinical evidence for medical technology but very little shared understanding. This platform is the first I’m aware of that aims to bring everyone together to do that.”
The joint EFGCP-MedTech Europe “Medical Technology Working Party” will involve stakeholders in a dialogue and seek to ensure that these standards are broadly accepted and reliably introduced in the rapidly developing, diverse medical technology landscape. A series of five workshops will look at various aspects of clinical evidence for in vitro diagnostics and medical devices. They are planned to take place throughout 2015 and will cumulate in a Plenary Conference in February 2016.
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Kick-off of the “Roadmap for Medical Device Development in Europe”: Establishing Best Practices in Clinical Development of In Vitro Diagnostics, Companion Diagnostics and Healthcare Apps: Barriers and Pathways to Success -- 7 & 8 May 2015 – Chamber of Commerce and Industry of Serbia, Belgrade, Serbia.
About the European Forum for Good Clinical Practice
The European Forum for Good Clinical Practice (EFGCP) is a non-profit organisation established by and for individuals with a professional involvement in the conduct of biomedical research. Its purpose is to promote Good Clinical Practice (GCP) and encourage the practice of common, high-quality standards in all stages of biomedical research throughout Europe and globally. The EFGCP does this by promoting contact and partnership between the major disciplines and organisations affected by good clinical practice: pharmaceutical companies; contract research organisations; suppliers of services, systems and equipment; academia; investigators; ethics committees; regulatory authorities; patient organisations; etc. For more information, visit www.efgcp.eu.
Ingrid Klingmann, MD, PhD
Chairman of the Board, EFGCP
T: 032 (0)2 784 36 93
M: +32 (0)475 29 59 18
About MedTech Europe
MedTech Europe is an alliance of European medical technology industry associations. The Alliance was founded by EDMA, representing the European in vitro diagnostic industry, and Eucomed, representing the European medical devices industry. Other European medical technology associations are welcome to join the Alliance, established to represent the common policy interests of its members more effectively and efficiently.
Our mission is to make value-based, innovative medical technology available to more people, while supporting the transformation of healthcare systems onto a sustainable path. We promote a balanced policy environment that enables the medical technology industry to meet the growing healthcare needs and expectations of its stakeholders. In addition, we demonstrate the value of medical technology by encouraging our members to execute the industry’s 5-year strategy. For more information, visit www.medtecheurope.org.