The Regulation on Medical Devices is changing the landscape for the development of medical devices in Europe but many elements of this Regulation are in transition and require in depth discussion between all stakeholders. The European Forum for Good Clinical Practice and MedTech Europe, 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).

This Working Party is offering a platform for discussion on issues in the new Regulation. The aim is to allow stakeholders to elaborate the most suitable solutions for the future development of medical technology with the patient at the centre.

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 is seeking to attract and involve a broad group of stakeholders and experts, (e.g: 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 reliably introduced in the technology landscape. Our ultimate goal is to ensure the advancement of innovative, safe and relevant medical technology in Europe.