EFGCP Medical Technology Stakeholder Alliance
The upcoming Regulation on Medical Devices will change the landscape for the development of medical devices in Europe but many elements of this Regulation are not yet agreed and require in depth discussion between all stakeholders, The European Forum for Good Clinical Practice and MedTech Europe (+link), the alliance of European medical technology industry associations, have created a common Working Party aiming to address ethical and quality issues when setting standards for the rapidly developing medical technology sector (medical devices and in vitro diagnostics).
The new Working Party will offer a platform for an exchange of views and opinions on topics of particular complexity and concern in the new Regulation and will allow stakeholders to jointly elaborate which solutions would be most suitable for the future development of medical technology and, above all, for the patient who will be the core concern of the Working Party.
The interest in tailoring the technology to the needs of the patients, and in ensuring quality and ethical principles and standards in clinical trial performance, are shared by both the medtech industry and EFGCP.
To reach its objectives, the Working Party will seek to attract and involve a broad group of stakeholders and experts, including patients, healthcare professionals, representatives from national and European competent authorities, notified bodies and ethics committees, lab technicians, and industry representatives, in a dialogue to make sure these principles and standards will be broadly accepted and reliably introduced in the technology landscape to ensure the advancement of innovative, safe and relevant medical technology in Europe.
First activities will include organisation of workshops to cover topics such as state-of-the-art medical device development, clinical trial methodology, regulation implementation aspects, etc. with a view to ensure appropriate regulation on clinical evidence for medical devices.
Contact the Chairpersons
Dr. Ingrid Klingmann & Mr. Eric Klasen
Square de Meeûs
Rue de l'Industrie 4
Tel +32 2 732 87 83
E-mail: email@example.com / firstname.lastname@example.org