Towards a regulation that guarantees patient safety, ensures patient access and keeps innovation in Europe

Eucomed’s response to the Commission’s proposal for the revision of the EU Medical Devices Directives

Executive Summary

Towards a regulation that guarantees patient safety, ensures patient access and keeps innovation in Europe

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:

• guarantees the highest level of safety for patients;
• ensures timely access to the latest innovative technologies;
• enjoys the trust of its stakeholders;
• contributes to the sustainability of national healthcare systems;
• maintains an environment that encourages and keeps research and innovation in Europe.

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.

Getting the regulation right: 7 key focal areas

The Commission’s proposal represents a step in the right direction and the majority of the recommended measures are welcomed by industry as they: (1) improve patient safety, (2) do not unnecessary delay patient access to medical devices that save or improve lives and (3) do not hamper innovation.

However, further improvements to the Commission’s proposal are necessary and should be brought to seven key focal areas to improve the delivery of safe, innovative medical technology that Europe’s patients need:

1. Only the best Notified Bodies should be allowed to approve medical devices to the market in order to ensure that the backbone of Europe’s decentralised system meets the highest safety and quality standards.
2. A systematic control procedure is necessary to improve the system and increase patient safety. The proposed ‘Commission scrutiny procedure’ (article 44) is inappropriate because it is not systematic and will not lead to increased patient safety. It should be replaced with a systematic control procedure (that goes beyond the current proposed measures). Only then will we reach the outcome that is desired by all stakeholders: maximum safety for all Europeans without unnecessary delay or duplication of work.
3. Increase stakeholder involvement to ensure that the opinions of essential healthcare actors are heard.
4. Greater transparency and traceability is critical to ensure that patients, doctors, industry and other stakeholders have access to clear information about the medical devices they use.
5. Clinical evidence needs more clarity as clear, appropriate requirements for clinical evidence are paramount to demonstrate that devices perform well and are safe for patients when used by a well-trained healthcare professional and as intended by the manufacturer.
6. Enhance vigilance and market surveillance to allow for rapid identification of adverse events and to ensure coherent and timely action by Member States.
7. Clear science based classifications are needed to avoid the currently proposed arbitrary reclassification of families of medical devices without any scientific or other justification, which will lead to global confusion. Clear and science based procedures must be followed to ensure that devices are appropriately classified.

Additional issues

The Medical Devices Directives are broad in scope and cover several important areas. Eucomed believes the following areas also need considerable attention because, although the topics may seem very technical, if not thought through correctly their impact can be very detrimental to Europe’s patients and on-going innovation:

Eucomed’s detailed position per issue is available in a series of fact sheets available on our website eucomed.org.

A clear, predictable and effective regulatory framework for Europe

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”.

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