This initiative is aimed at answering the question, "what constitutes - ‘high quality’ of clinical evidence for medical technology?" in particular from ethical, patient, clinical, and regulatory perspectives.
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.
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.
In the Workshop Report from December 2014 and in a solution-oriented Workshop Programme for May 2015, 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.
A first mover in creating shared understanding
John Brennan from MedTech Europe noted that “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.
Source: Press release MedTech Europe