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European Commission

Neven MIMICA

Commissioner for Consumer Policy

Medical Devices: new legislation to tackle new challenges

MEDTECH FORUM 2013/Brussels

11 October 2013

Ladies and Gentlemen,

Let me first of all thank the organisers for bringing together so many experienced and knowledgeable professionals in the field of medical devices and in vitro diagnostics for this year's MedTech Forum. I believe in dialogue and it was a pleasure for me to accept your invitation.

Ladies and Gentlemen,

Medical devices and diagnostics are essential tools of our outstanding healthcare systems in Europe. Without your products, our doctors could not provide the state-of-the-art healthcare that we are proud of in Europe.

At the same time, your sector is an important driver of the Union’s economic growth and competitiveness. It is a major provider of high-skill jobs and contributes significantly to research and innovation.

The world of devices and diagnostics is undergoing rapid and profound changes as you indicate in the title of this year's Forum:

  • The expectations and needs of the users as well as the possibility to deliver care are evolving;

  • In the aftermath of the recent fiscal and economic crisis, the economic governance in Europe is changing;

  • The regulatory environment is being adapted in light of recent developments;

  • And we see a growing need to extend cooperation to the global level.

Let me briefly address these changes, all of which have a major impact for your sector.

Innovation in medical devices and in vitro diagnostic medical devices has gathered pace in recent years. Scientific and technological advances, for example, in drug-device combination products, tissue engineering, information and communication technologies, nano-science, personalised medicine and genetics, are creating new opportunities for improving healthcare and could culminate in a revolution in the way healthcare services are delivered.

Let me mention just two examples: Modern telemedicine allows patients to have regular check-ups from home, rather than visit a doctor or even travel to a hospital. And modern devices enable less invasive surgery significantly reducing the risk from and the cost of operating.

With their low share in Member States' healthcare spending1, medical devices and in vitro diagnostic medical devices offer alternatives to systematic or long-term hospitalisation. In doing so, medical devices support the long-term sustainability and efficiency of healthcare systems against a backdrop of fiscal consolidation.

This leads me to the second major change, namely that of the economic governance in Europe.

To ensure that Member States make progress in achieving the Europe 2020 Agenda for Smart, Sustainable and Inclusive Growth, the European Union has agreed on "The European Semester" - a yearly cycle of economic and fiscal policy coordination.

Each year Country-Specific Recommendations are addressed to Member States to help them tackle the structural challenges they face.

Moreover, as from this year, there new rules in place for countries which adopt the Euro: their public budget will be assessed every year, to ensure enhanced fiscal stability.

Over the last three years healthcare has received increasing attention in this process.

In the 2013 European Semester, 11 Member States received Recommendations to reform their health systems.

In addition to this, the reform programmes for the 4 Member States which currently receive financial assistance from the Commission, the ECB and the IMF include recommendations on ways to reform health systems and optimise health expenditure.

Clearly, in the current economic and fiscal climate, health expenditure issues are in the limelight. Our common task remains an insistence on proportionality of reforms and fiscal discipline measures that should never put at risk the sustainability of the health system.

In previous years the low-hanging fruits have been picked. Quick efficiency gains were made by reducing prices for pharmaceuticals and even cutting public pay levels.

However, it is now clear that more long-term and structural changes are required to ensure access to good quality healthcare for EU citizens in the long run.

This year's European Semester Recommendations bear testimony to this need for a more transformational change of Europe's health systems.

For one, focus is put on making healthcare delivery less hospital-centric. Such a change will require further integration of care practices across healthcare providers. Of course, information flows will have to follow the patient for systems to successfully become less hospital-centric.

Similarly, 7 European Semester Recommendations were addressed to Member States focusing on reforming long-term care systems. Here too, the industry has a role to play in ensuring people can retain and improve their independence and autonomy for as long as possible.

Clearly, health systems of the future will leverage technological solutions delivered by the industry to achieve this change.

Ladies and Gentlemen,

This leads me to the third change, the one you probably are most curious about today, namely that of the regulatory environment.

The regulatory framework is not an end it itself. Its purpose is to ensure that the valuable and powerful innovation in your sector flourishes in a way as to fully benefit the patients. This requires of course that patient safety is not put at risk. At the same time, this framework must be flexible enough to reap the benefits that innovation in your sector can bring for the sustainability of our healthcare and the competitiveness of your sector.

The two Commission proposals to revise the legislation for medical devices and diagnostics were presented at last year's Forum. So instead of going over the details again, let me simply recall the underlying fundamentals, as they will determine the Commission's position in the next months.

The two proposals are of the highest importance for patient safety. They are needed to respond to innovation in products, such as drug-device combinations. They are needed to reflect regulatory developments both at European level through the New Legislative Framework and at global level through the former Global Harmonisation Task Force.

They are needed as experience showed that the existing Directives were not always complied in a coherent manner, for example on the safety reporting.

After the Commission had already launched preparations for the on-going revision, a number of incidents re-confirmed weaknesses in today's legislation. Even if fraud can never be fully prevented, the current framework allowed the fraud by PIP to remain undetected for ten years.

For these reasons, I am strongly convinced that the two proposals need to be adopted under this legislature.

They considerably strengthen the rules for the placing on the market of medical devices, in particular with regard to the assessment of high risk devices, the requirements on notified bodies and the rules governing vigilance and market surveillance. Let me give you just one example: On the basis of today's legislation, we will not be able to force notified bodies to do unannounced audits. We can only recommend it. To make it obligatory, we need to change the law.

At the same time, the proposals remain proportionate to ensure that Europe stays at the forefront of innovation in this important sector. On the system for approval of high-risk medical devices for example, the Commission proposal is clear: It is a procedure aimed at operating as an exceptional safeguard. I hope that this will remain its nature in the outcome of the legislative process. A pre-marketing authorisation system similar to that for pharmaceuticals would be detrimental to innovation without added value for patient safety.

Similarly, for reprocessing of single-use medical devices, the Commission proposal contains strict, but justified, rules on the reprocessing based on the latest scientific evidence. It would allow the practice of reprocessing to develop further under clear and safe conditions leading to potential savings for healthcare systems.

Regarding the criteria and process for designation of notified bodies, especially for certain types of devices, some constructive proposals have been made, both in the Council and in the Parliament.

In relation to in vitro diagnostic medical devices, the Commission proposal also considerably reinforces the rules currently in place especially when it comes to risk classification and clinical evidence. This will ensure the highest and most homogeneous level of patient safety throughout the Union.

The European Parliament has worked intensively in order to achieve this objective. I welcome the vote in the Environment, Public Health and Food Safety Committee two weeks ago: it paves the way for discussions between the institutions to achieve the most balanced and proportionate solution.

I am also in close and regular contact with the Lithuanian and the Greek Presidencies and I am confident in their commitment to achieve adoption of the two Regulations during the current mandate of the Parliament.

To this goal, in preparations for the Trialogue, the Commission will carefully and thoroughly analyse the amendments that will be adopted by the EP Plenary as well as the position of the Council. At the same time we would be open to further improve our own proposal while respecting the balance between patients' safety and innovation in the sector.

Ladies and Gentlemen,

Let me now turn to the fourth and last change, namely the increasing importance of international cooperation.

At international level, the European Union holds the Chair of the International Medical Device Regulators' Forum for the year 2013.

The six working groups have made great progress in their respective areas, and, as Chair, we hope that new finalised working documents will be adopted at the November meeting of the Management Committee.

Under EU Chairmanship, the Forum is gaining more weight: an enlarged Management Committee, now formally including Brazil, China and Russia works together towards increased safety and greater innovation. The Open Session, that gathered over 100 stakeholders in France last March, has become a major venue for debating the future of medical devices' regulation.

Transatlantic cooperation is also gaining momentum in the context of the Transatlantic Trade and Investment Partnership. For medical devices, the Partnership could facilitate convergence towards a Unique Device Identification system.

It could enable the establishment of a harmonised template for data submission and of a common/interoperable system for electronic data submission. I believe we share the common interest to ensure maximum progress at the multilateral level, for instance, with regard to the Single Audit Programme, and to use the Partnership process with the US to complement this multilateral work.

At the same time, I have full confidence in my colleague Karel De Gucht and the EU negotiators to ensure that the Transatlantic Trade and Investment Partnership will not result in lowering the EU safety standards.

Ladies and Gentlemen,

Let me conclude by stating that I am very confident that together we can respond successfully to the changes which medical devices and diagnostics are currently undergoing. This is important in the interest of the health and the well-being of European citizens.

Now I am looking forward to your comments and questions as I am very interested to hear views.

Thank you for your attention.

1 :

Medical devices and in vitro diagnostic medical devices represented less than 5% of Member States' health expenditure in 2011 (e.g. 3% in Germany, 4% in the United-Kingdom, 5% in Sweden).


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