New EU expert think-tank see ks to answer the question, “what constitutes best-in-class standards of clinical evidence for innovative medical technologies and apps.” ; © panthermedia.net/ Andres Rodriguez
The joint European Forum for Good Clinical Practice (EFGCP) and MedTech Europe Working Party announced 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.
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 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.
MEDICA.de; Source: European Forum for Good Clinical Practice (EFGCP)