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
Date: 2012-09-26
Institutions: European Commission
Subjects: innovation, medical device, medical diagnosis, nursing staff, patient's rights, physician, test tube fertilisation

EUROPEAN COMMISSION 

Brussels, 26.9.2012  
COM(2012) 540 final 

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 

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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. 

2. 

2.1. 

2.2. 

2.3. 

2.4. 

3. 

3.1. 

Introduction .................................................................................................................. 3 

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

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

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

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

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

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

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. 

3.4. 

4. 

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

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

Conclusion.................................................................................................................... 9 

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1. 

INTRODUCTION 

This  Communication,  together  with  the  two  proposed  Regulations  to  revise  the  European 
Union legislation on medical devices1 and in vitro diagnostic medical devices2, constitutes a 
response to the Council Conclusions on innovation in the medical device sector adopted on 6 
June 20113 and to the European Parliament Resolution on defective silicone breast implants 
adopted on 14 June 20124. 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 disease6. 

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 professionals7. 

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 

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Medical devices include products such as sticking plasters, contact lenses, dental filling materials, x-ray 
machines, pacemakers, breast implants or hip replacements. 
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) 
OJ C 202, 8.7.2011, p. 7 
P7_TA(2012)0262 
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  
The future of healthcare in Europe — A report from the Economist Intelligence Unit. 
Green Paper on the European Workforce for Health, COM(2008) 725 final, 10.12.2008. 

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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  countries8  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 

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EU Member States, EFTA countries and Turkey 

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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 Force9 (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 
Forum10,  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: 

• 

• 

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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; 

http://www.ghtf.org/ 
http://www.imdrf.org/ 

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• 

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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 

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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)  market11,  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.  

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World Bank, EDMA, Espicom and Eucomed calculations, 2009 

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

3.2.1.  Digital Agenda for Europe12 

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  Plan13  and  the  Directive  on  the  application  of  patients’  rights  in  cross-border 
healthcare14.  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 Union15 

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 

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COM(2010) 245 final/2 
COM(2004) 356 final 
OJ L 88, 4.4.2011, p.45 
COM(2010) 546 final 
Espicom Health-care Intelligence — Medical Market Forecasts to 2011 

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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 activities17. 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 

17 

OJ L412, 30.12.2006, p1 

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benefits  of  safe,  effective  and  innovative  medical  devices  and  in  vitro  diagnostic  medical 
devices. 

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