Eucomed notes a number of areas that still raise concern, many of which were mirrored most recently in the June 2015 Council meeting. Thus the text still warrants further work to fully meet the policy objectives and to be clear, applicable and feasible.
Eucomed believes that the following five areas merit particular attention and must be addressed:
- The ‘Scrutiny’ mechanism. Redundant with other improvements, but if there, at least make it workable and predictable
- Clinical evidence. Maintain the Commission’s and a much simplified Council case-by-case approach and get the definitions of clinical data and clinical equivalence scientifically sound
- Re-use of single-use medical devices. Ensure a single high harmonised level of safety across the EU as per Commission proposal with hospitals and subcontractors appropriately covered
- Hazardous substances. Support the feasible, scientific and proportionate approach of the Commission
- Unnecessary added complexity and disproportionate measures. Strip out unfeasible, disproportionate or duplicative requirements and reverse unjustified reclassifications
Read Eucomed’s full position paper here.
The revision of the EU Medical Devices Directives has entered a critical phase. The European Parliament has finalised its report and must now work together with the EU Council towards agreement on a final text. The medical device industry has identified four key issues which it believes warrant special attention during this process. These include:
Read Eucomed’s full position paper here.
The European medical device industry is a critical provider of innovative, effective and safe healthcare solutions for an increasing number of patients in Europe. Through its healthcare innovations, the industry contributes to ensuring sustainable and accessible healthcare systems throughout Europe.
The European Medical Device industry recognizes that the system needs an overhaul due to increased expectations and technological advances, and acknowledges that change is necessary to improve Europe’s Medical Device regulatory framework. In particular, the European Medical Device industry unanimously agrees that incidents like the fraudulent PIP breast implant case should never happen again.
In the global context, let us not forget that Europe has been known for providing its citizens with timely access to safe technology thanks to the effective decentralised approval system. The European system (see also Appendix 1) forms a significant basis for other national regulatory frameworks around the globe (e.g. Japan, Australia, Canada) because of its efficiency in providing lifesaving and life-enhancing technologies to patients and doctors while guaranteeing a high level of safety.
Various recent reports from respected academics and researchers have shown that lifesaving and life-enhancing medical technologies are made available to European patients on average of three to five years earlier than those in the United States - and this without compromising safety.
We are convinced that Europe can remain in this leading situation with the support of an improved decentralised, device-specific regulatory framework that assures safety, encourages cost-effective innovation and ensures that an incident such as the PIP case will not happen again.
We strongly believe that it is in Europe’s best interest to have a clear, predictable and effective regulatory system that:
We welcome the majority of the recommended measures in the Commission’s proposal for the revision of the EU Medical Devices Directives (MDD), and acknowledge their importance in achieving the above mentioned objectives.
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”.