# EUR-Lex - 52012DC0540 - EN

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# 52012DC0540

**COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals /* COM/2012/0540 final */**

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COMMUNICATION FROM THE COMMISSION TO
THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL
COMMITTEE AND THE COMMITTEE OF THE REGIONS

Safe, effective and innovative medical
devices and in vitro diagnostic medical devices for the benefit of patients,
consumers and healthcare professionals

TABLE OF CONTENTS

1........... Introduction.................................................................................................................... 3

2........... The need for a safe, transparent
and sustainable legislation............................................... 4

2.1........ The legislation — a foundation
for safe, effective and innovative medical devices and in vitro diagnostic medical devices........................................................................................................................... 4

2.2........ The need to restore patients',
consumers' and healthcare professionals' confidence........... 4

2.3........ The necessity to adapt to a
global market........................................................................ 5

2.4........ Towards a safer, more transparent
and sustainable legislation........................................... 5

3........... A contribution to the objectives of the Europe 2020 Strategy........................................... 6

3.1........ The medical device and in vitro diagnostic
medical devices sectors —key drivers for the European Union’s economic growth............................................................................................................ 6

3.2........ Medical devices and in vitro diagnostic medical devices
support smart growth.................. 8

3.2.1..... Digital Agenda for Europe............................................................................................... 8

3.2.2..... Innovation Union............................................................................................................ 8

3.3........ Medical
devices and in vitro diagnostic
medical devices support sustainable growth.......... 9

3.4........ Medical devices and in vitro diagnostic medical devices
support inclusive growth.............. 9

4........... Conclusion..................................................................................................................... 9

1.           Introduction

This Communication, together with
the two proposed Regulations to revise the European Union legislation on
medical devices[1]
and in vitro diagnostic
medical devices[2], constitutes a response to the Council
Conclusions on innovation in the medical device sector adopted on 6 June 2011[3] and to the European Parliament Resolution on defective
silicone breast implants adopted on 14 June 2012[4]. Both the Council and the European Parliament have pointed
to the necessity to adapt the medical device legislation to the needs of
tomorrow with the aim to achieve a suitable, robust, transparent and
sustainable regulatory framework. Such framework should be central to fostering
the development of safe, effective and innovative medical devices and in vitro diagnostic medical devices, for the benefit of European patients,
consumers and healthcare professionals.

Health is indeed central to people’s
lives. It is ranked among the top priorities and concerns of European citizens.
The right of access to safe products and quality healthcare services is also
one of the most fundamental rights.

Demographic and societal changes, coupled with scientific
progress, have been transforming healthcare delivery models and the innovation
process significantly in recent
decades. This will certainly continue to be the case.

The needs,
roles, knowledge and expectations of patients,
consumers and healthcare professionals have evolved considerably. It is estimated that, in 2060, there will be twice as many Europeans
aged 65 or over (152.6 million in 2060 compared to 87.5
million in 2010)[5].
An ageing population and changes in lifestyle will lead to an important evolution
in disease patterns, with an increasing prevalence of chronic, and often
multiple, diseases, such as cancer, diabetes, heart diseases, respiratory
conditions, stroke, dementia and depression. In 2010, over one-third of
Europe’s population was estimated to have developed at least one chronic
disease[6].

These changes come at a time of constantly increasing pressure on healthcare
budgets, exacerbated by the recent global economic and financial crisis, and a
steady decline in the number of healthcare professionals[7].

In this
evolving and challenging context, medical devices and in vitro
diagnostic medical devices will be of increasing importance to public health
and medical care.

It is therefore essential to create the right conditions
for safe, effective and innovative medical devices and in vitro
diagnostic medical devices to deploy within a secured and well-functioning
internal market, while duly taking into account the peculiarities of each of
these sectors in their respective Regulation. These are
a prerequisite to ensuring the highest level of health protection that
patients, consumers and healthcare professionals are entitled to expect. They
are also vital to meet future demographic, societal
and scientific challenges, improve European industry
competitiveness, and thus achieve the smart, sustainable and inclusive
growth that is so central to Europe 2020 Strategy.

2.           The need for a safe, transparent and sustainable
legislation

2.1.        The legislation — a foundation for safe, effective and
innovative medical devices and in vitro diagnostic medical devices

Appropriate legislation is fundamental to ensuring the
highest level of health protection and effective innovation. It is also
necessary for the good functioning of the internal market, which represents a
major source of growth and jobs, and the effectiveness of European Union’s
external trade.

Appropriate legislation shall:

·
give patients, consumers and healthcare
professionals confidence in the devices they might use every day;

·
allow industry to bring safe, effective and innovative
products to market quickly and efficiently;

·
increase the ability of innovative companies to
attract investors, estimate costs and anticipate procedures.

Over the last 20 years, the medical device and the in vitro diagnostic medical device
Directives have, overall, provided for safe, reliable
and high-performing products in the European Union. They have ensured the
flexibility needed to take account of the diversity of devices and their short
life-cycle, and have proven to be favourable frameworks for innovation and
small to medium-sized enterprises.

This practice needs to be maintained and developed
further.

Translating discoveries and
inventions into safe, effective and innovative devices that can reach patients, consumers and healthcare professionals in a timely manner is of the utmost importance, first of all for
public health, but also for economic growth, the development of these sectors,
their competitiveness and the jobs they create.

2.2.        The need to restore patients', consumers' and
healthcare professionals' confidence

Confidence and innovation must remain
complementary and mutually supporting aspects of the promotion of public health.

Science evolves quickly in the areas of medical devices and
in vitro diagnostic medical devices. In an internal market of 32
participating countries[8]
that are subject to constant technological and scientific progress, important differences
in interpreting and applying the rules have emerged, thus undermining the legislation's
main objectives — the safety of devices and their free circulation within the
internal market. Moreover, there are regulatory gaps or uncertainties with
regard to certain products. The regulatory system has also suffered from a lack
of transparency and shortcomings in its implementation, in particular in the fields of market surveillance, vigilance and the functioning
of notified bodies.

In addition, recent
serious incidents involving medical implants (e.g. breast implants,
metal-on-metal hip replacements) have put patient safety at risk and have,
without doubt, badly damaged the confidence of patients,
consumers and healthcare professionals in the safety of the devices on which they may rely every day. These incidents have revealed further shortcomings of the current
legislation, especially with regard to post-market controls.

This calls for determined action.

2.3.        The necessity to adapt to a global market

The medical device and the in vitro diagnostic
medical device markets have also become increasingly globalised. The European Union
has, in the two last decades, encouraged regulatory convergence with its major
trading partners (i.e. the United States, Canada, Australia and Japan)
within the Global Harmonization Task Force[9]
(GHTF), with the aim of ensuring the safety and the quality of devices,
promoting technological innovation and facilitating international trade. The
results of this international cooperation are being implemented not only in the
participating jurisdictions, but also by many other countries that use the GHTF
regulatory model as a blueprint for their national regulations. International
cooperation will be strengthened further in the new International Medical
Device Regulators Forum[10],
with a view to continue developing efficient and effective regulatory models
for medical devices and in vitro diagnostic medical devices that protect
and maximise public health and safety while being responsive to innovation. To
the extent possible, guidance developed for medical devices and in vitro diagnostic
medical devices at international level have been taken into account in the
proposed Regulations, in particular in the fields of traceability, safety and
performance requirements, risk classification and clinical evaluation This will
contribute to promote the global convergence of regulations, ensure a high
level of safety protection worldwide and facilitate international trade. In
addition the proposed Regulations encourage the regulatory cooperation between
European regulators and their counterparts outside the European Union.

2.4.        Towards a safer, more transparent and sustainable
legislation

Strengthening the legislation is a
prerequisite for the European Union capacity to continue to ensure a high level
of health protection, restore the confidence of patients, consumers and healthcare
professionals, and foster innovation and
competitiveness.

In particular, the proposed Regulations
foresee:

·
to amend and clarify the scope of the
legislation, to take into account scientific and technological progress and
respond to tomorrow's needs. It is extended to include,
for example, implants for aesthetic purposes and clarified as regards genetic
tests;

·
to strenghten the supervision of the notified
bodies by the Member States, in order to ensure that all bodies have the
necessary competence to carry out the pre-market assessment of devices;

·
to guarantee the independency and the quality of
pre-market assessment of devices, by clarifying and enhancing the position and
powers of notified bodies vis-à-vis the manufacturers (e.g. regular
checks on manufacturers, including unannounced factory inspections) and by
providing an appropriate level of intervention of public authorities;

·
to clarify the obligations and responsibilities
of manufacturers, importers and distributors. This encompasses diagnostic services,
internet sales and parallel trade;

·
to ensure transparency, in particular through an expanded European database on medical devices and in vitro
diagnostic medical devices partially accessible to the public. It will provide patients,
healthcare professionals and the public at large with comprehensive information
on products available on the EU market, enabling them to make better informed
decisions;

·
to increase devices traceability throughout the supply chain, by requiring that manufacturers, on a risk-based approach, fit their devices
with a Unique Device Identifier (UDI). This will allow fast and effective measures in case of safety problems;

·
to reinforce the rules governing clinical
evaluation throughout the life of medical devices and in vitro diagnostic
medical devices, to ensure patient and consumer safety;

·
to strenghthen the provisions governing market surveillance and vigilance,
allowing better coordination between authorities to ensure rapid and consistent
responses to safety issues;

·
to make the management of the system more robust
through mechanisms of effective coordination between authorities, with
scientific support by the Commission, in order to ensure a uniform and
sustainable implementation of the future Regulations.

3.           A contribution to the
objectives of the Europe 2020 Strategy

3.1.        The medical device and in vitro diagnostic medical devices sectors —key drivers
for the European Union’s economic growth

The medical device and the in vitro diagnostic
medical devices sectors are estimated to comprise more than 500,000 products, covering
a wide range of devices from simple bandages to the most sophisticated
life-supporting devices. Medical devices and in vitro diagnostic medical
devices play a crucial and complementary role in the diagnosis, prevention
monitoring and treatment of diseases, the safety of the blood used in
transfusions, and the improvement of the quality of life of people suffering
from disabilities.

The medical device and in vitro
diagnostic medical device sectors are characterised by
a high degree of innovation, both incremental — once a
device reaches the market, improvements may follow within 18 to 24 months — and
breakthrough innovation.

The European Union has solid assets in the medical
device and in vitro
diagnostic medical devices fields and, without doubt, considerable
potential to deliver growth. Not only the European Union has the largest market
and some of the biggest companies in the world, but it also has an expanding
ecosystem of innovative small to medium-sized enterprises, and even micro
enterprises, which are the innovators of the future. The medical device and in vitro diagnostic medical devices sectors have already proven to be key drivers of European economic
growth. They contribute substantially to European Union’s balance of trade,
employs more than 500,000 people in about 25,000 companies, 80 % of medical
devices companies and 95% of in vitro diagnostic medical devices companies being
small to medium-sized or micro enterprises. In 2009, they generated annual sales
of around EUR 95 billion (EUR 85 billion for medical
devices and EUR 10 billion for in vitro diagnostic medical devices) in the European (EU/EFTA) market[11], the main markets being Germany (EUR 21
billion for medical devices and EUR 2.17 billion for in vitro diagnostic
medical devices), France (EUR
17 billion for medical devices and EUR 1.7 billion for in vitro
diagnostic medical devices) and the United-Kingdom (EUR 11 billion for medical devices and EUR 0.7 billion for in
vitro diagnostic medical devices). Last but not
least, they are sectors that invest heavily in research and development, as
about 6-8 % of medical devices annual sales and 10% of in vitro diagnostic medical devices annual
sales are ploughed back into research each year, equivalent respectively to some EUR 6.5 billion
and some EUR 1 billion, usually through collaboration
with healthcare professionals and academia, in order to better identify and
respond to emerging medical needs.

Innovation in medical devices and
in vitro diagnostic medical devices has gained
pace in recent years. Scientific and technological progress, such as progress
in drug-device combination products, tissue engineering, information and communication technologies (ICT), nano-science,
personalised medicine and genetics, are creating new opportunities for
improving healthcare and could culminate in a revolution in how healthcare
services are delivered.

This innovation is central to the promotion of the
smart, sustainable and inclusive growth which the European Union is determined
to achieve through the Europe 2020 Strategy.

Safe and
innovative devices have the potential to:

·
keep people healthy and active for longer, by, for
example, offering solutions for disease prevention or early diagnosis; this has
a positive impact on productivity and competitiveness;

·
make the healthcare sector more sustainable, as
they can, for instance, help in preventing or reducing hospitalisation;

·
improve skills and create jobs, since the
healthcare sector employs one in ten of the most qualified workers in the
European Union.

With the proposed legislation,
the Commission aims also at maintaining the competitiveness and innovation
capacities of the medical device industry by further harmonising the rules
governing the medical device and the in vitro diagnostic medical device
sectors and the enforcement practices in the Member States. In particular, it
is estimated that the establishment of a central registration tool would help
reducing the administrative costs by up to EUR 157mio. Also an EU vigilance
portal with central reporting of serious incidents instead of multiple
reporting is expected to bring about non negligible reductions in
administrative costs.

3.2.        Medical
devices and in vitro diagnostic medical devices support smart growth

3.2.1.     Digital Agenda for Europe[12]

Progress in medical devices, in in vitro
diagnostic medical devices and in information and communication technology
(ICT) made it possible to radically transform the way healthcare services are
delivered and to identify potential solutions to the demographic, societal and
scientific challenges the European Union is facing.

In particular, over the last few years,
e-Health technologies — many of which are medical devices or in vitro
diagnostic medical devices — have created new possibilities for remote
diagnosis, monitoring or treating patients and reducing hospitalisation, thus
saving time and money for patients, healthcare providers and social security
systems. Such innovations may offer the chance to make healthcare systems more
efficient, thus providing equitable access to healthcare for millions of
European citizens. These objectives are critical given the increasing incidence
of chronic diseases, an ageing population and a shrinking healthcare workforce.

E-Health provides important opportunities
to improve overall healthcare delivery. However, to reap these benefits,
e-Health still presents challenges that the European Union is determined to
tackle through, in particular, the Digital Agenda for Europe, the e-Health
Action Plan[13]
and the Directive on the application of patients’ rights in cross-border
healthcare[14].
This is necessary to achieve interoperable e-Health services in the European
Union, to the benefit of patients (e.g. safety of treatments received
and delivery of care at the point of need), healthcare professionals (e.g.
improved quality and safety of care and up-to-date patient status information)
and industry (e.g. opening up competition, reducing development costs).

3.2.2.     Innovation Union[15]

Due to European Union’s ageing population and strong
competitive pressures from globalisation, future economic growth and jobs will
increasingly have to come from innovation, be they related to products,
services, processes, organisation or business models.

The Innovation Union initiative and its European
Innovation Partnerships, in particular the Partnership on Active and Healthy Ageing,
place great emphasis on the potential role of medical devices and in vitro diagnostic medical devices. By providing innovative solutions for prevention, early diagnosis,
monitoring and assistance for independent living, devices may indeed have a
crucial role to play in improving the health, mobility, independence and thus
quality of life of citizens, in particular the elderly.

3.3.        Medical devices and in vitro diagnostic medical devices
support sustainable growth

Globally, medical devices and in vitro diagnostic medical devices represented less than 5% of Member States' healthcare spending in
2011 (e.g. 3% in Germany, 4% in the United-Kingdom, 5% in Sweden)[16], and offer alternatives to
systematic or long-term hospitalisation, such as early diagnostic, minimally
invasive surgical devices or home-use devices. In doing so, medical devices
support the long-term sustainability and efficiency of healthcare systems and
have a positive impact on the productivity and competitiveness of the European
Union’s economy.

Medical devices and in vitro diagnostic medical devices are often an
integral part of modern hospital services, and the strong link between a device
and the surrounding environment often makes it difficult to correctly measure
the added value of introducing an innovative device. The European Union
supports projects aimed at improving health technology assessment methodologies
for devices through the Seventh Framework Programme of the European Community
for research, technological development and demonstration activities[17]. Improved methodologies will
make it easier for health decision-makers to identify which new devices can
contribute to efficiency gains and improved services. The
establishment of a voluntary European Health Technology Assessment (HTA)
network in 2013 will additionally enable easier sharing of HTA knowledge
concerning devices and other health technologies among Member States.

3.4.        Medical devices and in vitro diagnostic medical devices
support inclusive growth

As the medical device and in
vitro diagnostic medical devices sectors are comprised primarily of small to medium-sized and micro
enterprises, they are major providers of jobs, especially highly skilled jobs
in research and manufacturing, contributing directly to the Europe 2020 Strategy’s
aim to deliver high levels of employment.

Innovative solutions, for instance in the form of
telemedicine or assisting technologies, offer great potential for improving
access to medical services, combating health inequalities and social exclusion,
and enabling more people suffering from diseases or disabilities to live
independently and take an active part in society.

4.           Conclusion

Safe, effective and innovative medical
devices and in vitro diagnostic medical devices can certainly bring important benefits
to the health of European citizens. They are also crucial in helping the
European Union to meet current and upcoming demographic, societal and
scientific challenges.

Health is also a clear determinant of
economic growth. In this context, innovation in the medical device and in vitro
diagnostic medical device areas occupies a central place in initiatives falling
in the framework of the Europe 2020 Strategy, in particular under the
Innovation Union and the Digital Agenda for Europe flagship initiatives.

The proposed Regulations on medical devices
and on in vitro diagnostic medical devices have the objective of
bringing these two aspects together under two safe, transparent and sustainable
set of rules, built on a long-term vision. They will allow the European Union to
continue to ensure a high level of health protection and counteract emerging
doubts and decreased confidence of patients,
consumers and healthcare professionals in medical devices and in vitro
diagnostic medical devices, while at the same
time fostering innovation and competitiveness of these two sectors.

The proposed legislation is an essential ‘push’
factor for fostering a European Union of active and healthy citizens where
patients, consumers and healthcare professionals can reap the benefits of safe,
effective and innovative medical devices and in vitro diagnostic medical devices.

[1]               Medical devices include products such as sticking
plasters, contact lenses, dental filling materials, x-ray machines, pacemakers,
breast implants or hip replacements.

[2]               In vitro diagnostic medical devices include
products such as devices used to ensure the safety of blood transfusion (e.g.
blood grouping), detect infectious diseases (e.g. HIV), monitor
diseases (e.g. diabetes) and perform blood chemistry (e.g. cholesterol
measurement)

[3]               OJ C 202, 8.7.2011, p. 7

[4]               P7_TA(2012)0262

[5]               European Economy report - The 2012 Ageing Report:
Underlying Assumptions and Projection Methodologies to be found at:

http://ec.europa.eu/economy_finance/publications/european_economy/2011/pdf/ee-2011-4_en.pdf

[6]               The future of healthcare in Europe — A report from
the Economist Intelligence Unit.

[7]               Green Paper on the European Workforce for Health,
COM(2008) 725 final, 10.12.2008.

[8]               EU Member States, EFTA countries and Turkey

[9]               http://www.ghtf.org/

[10]             http://www.imdrf.org/

[11]             World Bank, EDMA, Espicom and Eucomed calculations,
2009

[12]             COM(2010) 245 final/2

[13]             COM(2004) 356 final

[14]             OJ L 88, 4.4.2011, p.45

[15]             COM(2010) 546 final

[16]             Espicom Health-care Intelligence — Medical Market
Forecasts to 2011

[17]             OJ L412, 30.12.2006, p1