The European Medical Technology Industry in figures 2021
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The European Medical Technology Industry in figures 2021
Table of contents What is Medical Technology? 3 Regulations 7 Innovation 11 Employment 15 Companies 19
Expenditure on Medical Technology 21 MedTech Market in Europe 25 Trade in Europe 33 About MedTech Europe 39
What is Medical Technology?
Medical technologies are products, services or solutions used to save and improve people’s lives.
In their many forms, they are with you all the time, from prevention to diagnosis and cure.
There are three main categories of medical technologies:
• Medical devices (MDs) are products, services or solutions that prevent, diagnose, monitor, treat and
care for human beings by physical means.
• In vitro diagnostics medical devices (IVDs) are non-invasive tests used on biological samples (for
example blood, urine or tissues) to determine the status of a person’s health.
• Digital health refer to tools and services that use information and communication technologies (ICTs) to
improve prevention, diagnosis, treatment, monitoring and management of health and lifestyle.
For the sake of this document, medical technology includes only medical devices and in vitro diagnostic
medical devices.
4
There are more than 500,000 medical technologies available in hospitals, community care settings and at home.
Medical technology can be everyday objects such as sticking plasters, syringes, surgical masks, or latex
gloves. It could also be spectacles, wheelchairs, COVID-19 tests or medical apps.
Medical technologies also include total body scanners, gene mutation tests, implantable devices such as
heart valves and pacemakers, and replacement joints for knees and hips.
You may not always notice medical technologies, but they are always there for you.
Medical technologies provide value in different ways. They allow people to live longer and better lives, thus
empowering them to contribute to society for longer. At the same time, medical technologies improve the
quality of care and the efficacy and sustainability of healthcare systems.
5
Medical technologies provide value in different ways. They allow people to live longer and better lives, thus
empowering them to contribute to society for longer. At the same time, medical technologies improve the
quality of care, and the efficiency and sustainability of healthcare systems.
6
Regulations
In the European Union, medical technologies are tightly regulated by laws that govern the safety and
performance of devices across their lifetime, pre- and post-market. Over the next few years, the European
medical technology sector will transition from being regulated under the current medical devices directives
to two new regulations.
8
Classification of In Vitro Diagnostic Medical Devices
Today, the in vitro diagnostic (IVD) sector is regulated by Directive 98/79/EC. From 26 May 2022, the new
Regulation 2017/746/EU will fully apply. Until this date, manufacturers can choose to comply with either the
Directive or the Regulation.
Classification of IVDs is important as it determines the level of involvement by a third party (the “notified
body”) in assessing IVDs both pre- and post-market. This level of control is generally relative to the risk of an
erroneous result from the assay.
Under the IVD Directive, IVDs are classified into four classes following a positive list approach:
Annex II Annex II Devices for Self-declared
List A List B self-testing devices
(e.g. ABO blood- (e.g. blood glucose (e.g. pregnancy (e.g. clinical
typing) monitoring) tests) chemistry analyser)
Under the IVD Regulation, all IVDs will be classified under a new risk-based classification system according
to the risk the device poses to the health of the public and or an individual as result of an incorrect test result.
All IVDs will be classified under class A, B, C or D, with class D being the highest risk class.
9Classification of Medical Devices
Since 26 May 2021, the medical device (MD) sector is regulated by Regulation (EU) 2017/745, the so-called
‘Medical Devices Regulation’ (MDR), which has come into full application. The MDR replaces Directives 93/42/EC
and 90/385/EEC and from 26 May 2021 on, no medical device can be certified under the old Directives anymore.
Classification of medical devices drives many pre- and post-market requirements. Due to the large variety of
products, the level of control made by a third-party (the “notified body”) before placing them in the market
depends on the level of impact on the human body that their use might imply. The same notified body is
involved post-market to ensure the continued safety and performance of medical devices.
Under the MD Directive, MDs were classified into 4 classes following a risk-based classification system:
Class I Class IIa Class IIb Class III
(e.g. simple (e.g. syringes for (e.g. anaesthesia (e.g. pacemakers)
bandages or wound pump infusion) machines)
care products)
Under the new MD Regulation, the risk-based classification system contained in the current Directives has been
maintained, although some changes have been introduced. The principle is the same: to link the class of the de-
vice to the potential risk posed to the health of the public and an individual as result of fault in the functioning.
All MDs are classified under class I, IIA, IIB or III, with class III being the highest risk class.
10Innovation
Medical technology is characterised by a constant flow of innovations, which are the results of a high level of
research and development within the industry, and of close co-operation with the users. The average global R&D
investment rate (R&D spend as a percentage of sales) is estimated to be around 8% in the medical technology
sector1. Products typically have a lifecycle of only 18-24 months before an improved product becomes available.
In 2020, more than 14,200 patent applications were filed with the European Patent Office (EPO) in the field of
medical technology representing a 2.6% growth in patent applications compared to the previous year2. The medical
technology field accounts for 8% of the total number of applications, the highest among all the sectors in Europe.
38% of these patent applications were filed from EPO countries (including EU27, UK, Norway and Switzerland) and
62% from other countries, out of which with the majority of applications filed from the US (39%).
In comparison, around 8,500 applications were filed in the pharmaceutical field and around 7,200 in the field
of biotechnology. While over the last decade the number of EPO filings in the field of medical technology
has doubled, pharma and biotech patent applications remained relatively stagnant. Furthermore, the ratio of
granted patents to patent applications has been steadily growing in the past years reaching 73% in 2020. In
contrast, the same ratio is less than 50% in the pharmaceutical and biotechnology field (Graph 2).
Patent application in medical technology field filed with EPO in 2020
62% 38%
Other countries EPO countries
(including EU27, NO, CH, UK)
12Graph 1 – Top 10 technical fields in patent applications
Number of patent applications filed with EPO, 2020 (ref. 2)
Medical technology 14.295
Digital communication 14.122
Computer technology 13.097
Electrical machinery, apparatus, energy 11.346
Transport 9.020
Pharmaceuticals 8.589
Measurement 8.582
Biotechnology 7.246
Other special machines 6.261
Organic fine chemistry 5.905
0 2,000 4,000 6,000 8,000 10,000 12,000 14,000 16,000Graph 2 – Evolution of European patent applications and granted patents by
technical field
2020 (ref 2.)
16,000 80%
14,000 70%
12,000 60%
10,000 50%
Granted Patents
Applications
8,000 40%
6,000 30%
4,000 20%
2,000 10%
0 0%
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
MedTech Applications Pharma Applications BioTech Applications
MedTech Granted Pharma Granted BioTech GrantedEmployment
The European medical technology industry employs directly more than 760,000 people3. Germany had the
highest absolute number of people employed in the medical technology sector, while the number of medical
technology employees per capita is highest in Ireland and Switzerland. In comparison, the European pharma-
ceutical industry employs around 795,000 people4.
The jobs created by the medical technology industry account for around 0.3% of total employment in Euro-
pe.5 These jobs are also highly productive, as the value added per employee is estimated to reach €184,000
per employee. These indicators show that the medical technology industry has an important economic and
societal impact in Europe.
760,000+
employees3
16Graph 3 – Top 10 countries in Europe with highest direct employment in
the medical technology industry
2020, or latest year available (ref. 3)
Sweden
Belgium 27,000
17,800 Austria Germany
United Kingdom
210,000
26,767
102,800
Ireland
Switzerland
40,000
63,000
France
89,130
Spain
27,800
Italy
94,153Graph 4 – Number of people directly employed in the medical technology
industry per 10,000 inhabitants
2020 or latest year available (ref. 3)
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83 74 30 29 27 25 16 16 15 13 12 9 9 7 6 5 4 3 3Companies
33,000
medical technology
companies in Europe
95%SMEs
There are more than 33,000 medical technology companies in Europe. The highest number of them are
based in Germany, followed by Italy, the UK, France and Switzerland. Small and medium-sized companies
(SMEs) make up around 95% of the medical technology industry, the majority of which employ less than 50
people (small and micro-sized companies)3.
20Expenditure on Medical Technology
€265 11%of GDP
expenditure on medical
spent on healthcare
technology per capita
in Europe
In Europe, an average of approximately 11% of gross domestic product (GDP) is spent on healthcare. Of this
figure, around 7.6% is attributed to medical technologies, i.e. less than 1% of GDP. The spending on medical
technology is estimated to vary significantly across European countries, ranging from around 5% to 12% of
the total healthcare expenditure. Expenditure on medical technology per capita in Europe is at around €265
(weighted average).*
* Medtech Europe calculation based on sources 4-8.
22Graph 5 – Breakdown of total healthcare expenditure in Europe
2020 (ref. 4–8)
14.9%* Pharmaceuticals &
other medical non-durables
7.6%
Medical Technology
0.8% In vitro diagnostics
6.9% Medical devices
(incl. imaging)
*2019 Pharmaceutical expenditure
is used for the calculation due to 77.6% Inpatient &
a lack of 2020 value outpatient care, other24
MedTech Market in Europe
€140
billion market
27.6%
of the world
market
2nd
largest market
after US
The European medical technology market is estimated at roughly €140 billion in 2020.7,8 The biggest medical
device markets in Europe are Germany, France, the United Kingdom, Italy and Spain. The same group of countries
forms the top 5 IVD markets in Europe. (Graphs 6 and 7)
Based upon manufacturer prices the European medical device market is estimated to make up 27.6% of the world
market. It is the second largest medical device market after the US (41.6%).8
26Graph 6 – European medical device market by country
2020 (ref. 8)
25.6% Germany
14.7% France
12.1% UK
9.1% Italy
6.3% Spain
4.4% Switzerland
3.9% Netherlands
3.3% Belgium
2.7% Sweden
2.6% Austria
15.2% OthersGraph 7 – European IVD market by country
2019 (ref. 7)
19% Germany
14% France
14% Italy
9% Spain
9% UK
4% Switzerland
4% Poland
4% Belgium
3% Netherlands
2% Austria
18% OtherGraph 8 – Europe in the world medical device market
2020 (ref. 8)
41.6% US
27.6% Europe
7.4% China
7.2% Japan
1.8% Canada
1.6% South Korea
1.3% India
11.6% OthersGraph 9 – European medical device market growth rates
2009-2020 (ref. 8)
15%
10%
USA Europe Japan China
43% 27% 7% 6%
5%
0%
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Canada Brazil Russia Others
2% 1% 1% 13%
-5%
The European medical device market has been growing on average by 2% per year over the past 10 years.
Demand fell in 2009 due to the economic crisis, resulting in a growth rate of only 1% (lowest in 12 years). The
market regained its pace in 2010, and since then the annual growth rate has varied between 2.6% (2013) and
9.3% (2015), being 8.5% in 2020.8
30Graph 10 – European IVD market growth rates
2009-2019 (ref. 7)
5%
4%
3%
2%
1%
0%
2013 2014 2015 2016 2017 2018 2019
-1%
-2%
-3%
-4%
The European medical device market has been growing on average by 2% per annum over the past 10 years.
Demand
The fell inIVD
European 2009 due growth
market to the economic
has been crisis,
slowing resulting in a 2013
down until growth rate
with of only
annual 1%. The
growth ratesmarket recovered
at around 2-4%.
in 2010,
The since
average then the
growth rateannual growth
since 2013 hasrate
beenhas varied
0.9% between
while 2.6 annual
the 2019 and 9.3% 7
growth rate for the European IVD
market was 1.5%.Graph 11 - European medical technology growth rates by sectors
2016-2020 (ref. 8)
40%
30%
20%
10%
0%
2016 2017 2018 2019 2020
-10%
-20%
-30%
Orthopaedics & prosthetics growth Dental products growth Consumables growth
Patient aids growth Other medical devices growth Diagnostic imaging growth
COVID-19 affected the medical technology industry in different ways. Postponement of elective surgeries
across EU countries led to deferred patient care within the Orthopaedics and Dental fields.
On the other end of the spectrum, sales of IVD (e.g. PCR tests), consumables (e.g. nasal cannulae, syringes,
surgical gloves) and patient aids (artificial respiration apparatus such as ventilators) products skyrocketed as
these medical technologies provided the special care severe COVID-19 patients require.Trade in Europe
€8.7billion
Estimation of Europe's
trade surplus in 2020
Europe has a positive medical devices trade balance of €8.7 billion (2020). Compared to the previous years, the
main European medical device trade partners remain the same: the US, China, Japan and Mexico.9
34Graph 12 - Top European medical technology export destinations
2020 (ref. 9)
Russia
Canada 4.6%
2.2%
Japan
USA 6.2%
South Korea
39.7% Turkey
1.8%
China
2.4%
Saudi Arabia
1.8% 11.8%
India
1.6%
Australia
3.1%Graph 13 – Top import suppliers to the European medical devices market
2020 (ref. 9)
USA Japan
4.9%
41.2% South Korea
Mexico
Israel China 1.5%
8.2%
1.9%
19.5%
Costa Rica Malaysia
2.6%
4.5%
Singapore
3.5%
Australia
1.7%Graph 14 – Export and import of medical devices by country
Including intra-community trade, million euros, 2020 (ref. 9)
GERMANY 28,096
19,166
25,403
NETHERLANDS 17,834
IRELAND 10,383
2,471
BELGIUM 10,033
9,116
SWITZERLAND 9,622
4,362
FRANCE 7,373
10,667
5,919
UK
8,841
ITALY 4,141
6,065
POLAND 2,968
2,564
AUSTRIA 2,171
2,286
DENMARK 1,894
1,554
FINLAND 1,730
1,030
SPAIN 1,608
4,873
1,531
SWEDEN
1,832
CZECH REPUBLIC 1,194
1,195
0 5,000 10,000 15,000 20,000 25,000 30,000
Export ImportGraph 15 – Medical devices trade balance by country
Including intra-community trade, million euros, 2020 (ref. 9)
GERMANY 8,930
IRELAND 7,912
NETHERLANDS 7,569
SWITZERLAND 5,260
BELGIUM 917
FINLAND 700
POLAND 404
DENMARK 340
LITHUANIA 53
MALTA 12
ESTONIA 4
-1 CZECH REPUBLIC
-15 BULGARIA
-47 LATVIA
-59 SLOVENIA
-74 CYPRUS
-100 LUXEMBOURG
-115 AUSTRIA
-216 SLOVAKIA
-219 HUNGARY
-248 CROATIA
-301 SWEDEN
-489 ROMANIA
-615 GREECE
-686 PORTUGAL
-886 NORWAY
-1,924 ITALY
-2,922 UK
-3,265 SPAIN
-3,294 FRANCE
-4,000 -2,000 0 2,000 4,000 6,000 8,000 10,000About MedTech Europe
MedTech Europe is the European trade association representing the medical technology industries, from
diagnosis to cure.
We represent diagnostics and medical devices manufacturers operating in Europe.
MedTech Europe’s mission is to make innovative medical technology available to more people while helping
healthcare systems move towards a sustainable path. MedTech Europe encourages policies that help the
medical technology industry meet Europe’s growing healthcare needs and expectations. It also promotes
medical technology’s value for Europe focusing on innovation and stakeholder relations, using economic
research and data, communications, industry events and training sessions.
MedTech Europe’s Facts & Figures publication is an annually updated report with robust industry data
compiled from multiple sources. The publication is used as the quintessential source of data by international
stakeholders seeking an up-to-date view of industry innovation and employment, SME activity, expenditure
on medical technology, trade and market size in Europe.
40Scope of this report
• In this report Europe refers to EU27, Norway, Switzerland and the United Kingdom, unless specified otherwise.
• The Innovation chapter defines medical technology following the methodology of the World Intellectual
Property Organization (based on the WIPO IPC-Technology concordance as revised in August 2014).
Patents are attributed by the country of residence of the applicant. EPO countries refer to the 38 member
states of the European Patent Organisation.
• The Employment and Companies chapters are based on data from the 2020 survey carried out among
MedTech Europe’s National Associations. Figures refer to the latest year available. An enterprise is considered
to be a SME if it employs fewer than 250 persons and has an annual turnover not exceeding € 50 million (small
and micro-sized companies employ fewer than 50 persons and have a turnover of less than € 10 million).
• The Expenditures on Medical Technology chapter is based on MedTech Europe calculations using healthcare
statistics from the following sources: EFPIA, Eurostat, Fitch Solutions, WHO.
• The MedTech Market in Europe chapter is based on manufacturers’ sales (revenue) not including margins, such
as value added in the wholesaling and retailing, transportation costs, some taxes included in the final price, etc.
• The Trade chapter data refers to the medical technology products in the following categories, excluding
in vitro diagnostics: orthopaedics & prosthetics, patient aids, dental products, diagnostics imaging,
consumables, other medical devices (incl. wheelchairs, ophthalmic instruments, hospital furniture, medical
& surgical sterilisers, ultra-violet or infra-red ray apparatus, blood pressure monitors, endoscopy apparatus,
dialysis apparatus, transfusion apparatus, anaesthetic apparatus & instruments).
41References
1 Evaluate MedTech, 2018, World Preview 2018, Outlook to 2024.
2 European Patent Office (EPO), 2021, Patent Index 2020.
3 MedTech Europe, 2020, National Associations Survey.
4 EFPIA, 2020, The Pharmaceutical Industry in figures.
5 Eurostat, 2021, Employment and Population Statistics.
6 WHO, 2019, Global Health Expenditure Database.
7 MedTech Europe, 2020, European IVD Market Statistics Report 2020. 2020 IVD market size data is
preliminary and is based on MedTech Europe Statistics Programmes
8 Fitch Solutions, 2021, Worldwide Medical Devices Market Factbook 2020.
9 International Trade Centre, 2021, International Trade Statistics – MedTech Europe calculations.
42www.medtecheurope.org
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