A clear, predictable and effective regulatory framework for Europe

Posted on 10.11.2015

Eucomed recognises the need to modernise and strengthen the current medical devices legislation in Europe, in particular, by strengthening the decentralised Notified Body system and increasing EU Member State co-ordination. The overarching objective should be to achieve a clear, predictable and effective legislative framework that is consistently implemented across the EU and increases patient safety, maintains timely access to the latest medical technologies and keeps Europe’s “medtech research and innovation engine” running.
This legislative framework should inspire trust in its stakeholders by addressing current systemic weaknesses and building on the strengths of what has proven to be the world’s best system for patients and medical progress. Europe has emerged as a leader in medical technology and we are convinced that we can remain in this privileged situation with the support of a decentralised, device-specific regulation that works for patients and innovation – a regulation that works for Europe.
In September 2012 former surgeon and Eucomed Chairman Dr. Guy Lebeau M.D. stated what remains paramount in the current process of revising the regulatory framework for devices:

“I know from first-hand experience that European patients and European medical research and innovation are benefitting heavily from our current system that is the world’s fastest in providing patients with lifesaving technologies while guaranteeing the highest level of safety.

As a surgeon first and as a business executive second, I fully agree that changes need to be made to the current regulatory framework but let’s make sure we keep the best system for patients and medical progress in Europe”.

Download Eucomed’s full response to the Commission’s proposal here.

Read the latest independent research on patient safety, access to innovative medical technology and innovation

• FDA Impact on U.S. Medical Technology Innovation, Josh Makower, MD & Consulting Professor of Medicine, Stanford university; November 2010
• EU Medical Device Approval Safety Assessment, A comparative analysis of medical device recalls 2005-2009, Boston Consulting Group, January 2011
• Regulation and Access to Innovative Medical Technologies, A comparison of the FDA and EU Approval Processes and their Impact on Patients and Industry, Boston Consulting Group, June 2012
• Pre-marketing authorization of new medical devices in the European Union and the United States, P.S. Abraham, J. Gholmie, E. Seoane-Vazquez, M. Rodriguez-Monguio; Massachusetts College of Pharmacy and Health Sciences University, University of Massachusetts, School of Public Health and Health Sciences; Value in Health, Volume 16, Issue 3, Page A267, May 2013