The European Medical

Technology Industry
– in figures / 2018
Table of contents

What is Medical Technology? 4

Innovation 10

Employment 14

Companies 18
Expenditure on Medical Technology 20

MedTech Market in Europe 24

Trade in Europe 32

About MedTech Europe 38

What is
Medical
Technology?
Medical technology is any technology used to save lives or transform the health of individ-
uals suffering from a wide range of conditions. In its many forms, medical technology is already
diagnosing, monitoring and treating virtually every disease or condition that affects us.

For the sake of this document, medical technology includes medical devices and in vitro diagnostic
medical devices. Medical devices are products intended to perform a therapeutic or diagnostic
action on human beings by physical means. In vitro diagnostic medical devices are products which
provide medically useful diagnostic information by examination of a specimen derived from the
human body.

What is Medical Technology? 5

There are more than 500,000 medical technologies currently available and they all share a com-
mon purpose: improving, extending and transforming people’s lives. Medical technology can be
familiar, everyday products such as blood glucose meters, sticking plasters, syringes or latex

Visual 1:at Diversity and classification of medical technology

gloves. Alternatively, it can also be pregnancy tests, spectacles, wheelchairs and hearing aids.

Medical Devices
Meanwhile, the high-tech end of the scale, medical technology includes molecular diagnostics,

In and
Vitropacemakers,
Diagnostics
total body scanners, ultrasounds, life-supporting machines, implantable devices such as heart
valves neurostimulators and replacement joints for knees and hips.

The common thread through all applications of medical technology is the beneficial impact on
health, quality of life and in society as a whole. Medical technologies contribute to living longer
and better, and empower citizens to contribute to society for longer. In so doing, they improve
the quality of care and the efficacy, efficiency and sustainability of healthcare systems.

6 What is Medical Technology?

Regulation and classification of medical technologies
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.

What is Medical Technology? 7

 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.

8 What is Medical Technology?

Classification of medical devices
The medical device (MD) sector is regulated by Directives 93/42/EC and 90/385/EEC. From
26 May 2020, the new Regulation 2017/745/EU will fully apply. Until this date, manufacturers
can choose to comply with either the Directives or the Regulation.

Classification of medical devices (estimated to be more than 500.000) 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 are 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/additions have been introduced. The
principle is the same: to link the class of the device 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.

What is Medical Technology? 9

Innovation
Medical technology is characterised by a constant flow of innovation, which is the result of
a high level of research and development within the industry, and of close co-operation with the
users. Products typically have a lifecycle of only 18-24 months before an improved product
becomes available.

In 2016, more than 12,200 patent applications were filed with the European Patent Office (EPO)
in the field of medical technology – 7.7% of the total number of applications –, still more than
any other sector in Europe. 41% of these patent applications were filed from European countries
(EU28, Norway and Switzerland) and 59% from other countries, out of which with the majority
of applications filed from the US (38%).

In comparison, around 5,700 applications were filed in the pharmaceutical field and around 5,700
also 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 were relatively stagnant1.

PATENT APPLICATION IN
MEDICAL TECHNOLOGY FIELD 41%
FILLED WITH EPO IN 2016 EU28, Norway
and Switzerland

59%
Other countries

Innovation 11
TOP 10 TECHNICAL FIELDS IN PATENT APPLICATIONS.
NUMBER OF PATENT APPLICATIONS FILED WITH EPO, 2016 (REF. 1)

12,263 MEDICAL TECHNOLOGY

10,915 DIGITAL COMMUNICATION

10,657 COMPUTER TECHNOLOGY

10,293 ELECTRICAL MACHINERY, APPARATUS, ENERGY

8,402 TRANSPORT

7,442 MEASUREMENT

6,301 ENGINES, PUMPS, TURBINES

6,189 ORGANIC FINE CHEMISTRY

5,754 PHARMACEUTICALS

5,744 BIOTECHNOLOGY
EVOLUTION OF EUROPEAN PATENT APPLICATIONS BY TECHNICAL FIELD (REF. 1)

14.000

12.000

10.000

8.000

6.000

4.000

2.000

0
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Medical technology
Biotechnology
Pharmaceuticals Innovation 13
Employment
 > 675,000 3

employees

The European medical technology industry employs more than 675,000 people.
Germany had the highest absolute number of people employed in the medical technology sector,
while the number of medtech employees per capita is highest in Ireland and Switzerland. This
high level of employment shows that the medical technology industry is an important player in
the European economy.

In comparison, the European pharmaceutical industry employs more than 740,000 people2.

Europe refers to EU 28, Norway and Switzerland unless specified otherwise. Employment 15
TOP 7 COUNTRIES WITH HIGHEST EMPLOYMENT IN THE MEDICAL TECHNOLOGY INDUSTRY (REF. 3)

United Germany
Kingdom

100,000 210,000
Ireland
Switzerland
35,000
54,000

France

85,000

Spain Italy
23,000 76,000

16 MedTech Market in Europe

 NUMBER OF PEOPLE DIRECTLY EMPLOYED IN THE MEDICAL TECHNOLOGY INDUSTRY
PER 10,000 INHABITANTS IN 2016 (REF. 3)

Ireland Switzerland Denmark Germany Sweden Belgium UK France Italy Netherlands Spain Greece Portugal

74 64 26 25 23 15 15 13 13 9 5 5 4

Employment 17
Companies
 27,000
medical technology
companies in Europe

95%
SMEs
There are approximately 27,000 medical technology companies in Europe. Most
of them are based in Germany, followed by the UK, Italy, Switzerland, France and Spain. Small
and medium-sized companies (SMEs*) make up almost 95% of the medical technology industry,
the majority of which employ less than 50 people (small and micro-sized companies)3.

*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 company- employs
fewer than 50 persons and has a turnover of less than €10 million). Companies 19
Expenditure
on Medical
Technology
 ¤203
Expenditure on
medical technology
per capita in Eu-

In Europe, an average of 10% of gross domestic product (GDP) is spent on health-

care. Of this figure, around 7.2% 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 10% of the total healthcare expenditure4. Expenditure on medical
technology per capita in Europe is at around €203 (weighted average).

Expenditure on Medical Technology 21

BREAKDOWN OF TOTAL HEALTHCARE EXPENDITURE IN EUROPE (REF. 5)

7.2%
Medical
technology
0.7%
In vitro
diagnostics

6.5%
Medical devices
(incl. imaging)
15.9%
Phamaceuticals
& other medical
non-durables
76.9%
Inpatient &
outpatient care,
other

22 Expenditure on Medical Technology

Expenditure on Medical Technology 23
MedTech Market
in Europe
 ¤110
billion market

The European medical technology market in 2016 is estimated at roughly

€110 billion6.

Based upon manufacturer prices the European medical technology market is estimated to make
up 29% of the world market. It is the second largest medical technology market after the US
(approximately 43%).

MedTech Market in Europe 25

EUROPEAN MEDICAL DEVICE MARKET BY COUNTRY,
BASED UPON MANUFACTURER PRICES, 2016 (REF. 6)

GERMANY FRANCE UK ITALY

28% 15% 12% 10%

SPAIN NETHERLANDS SWITZERLAND BELGIUM

6% 4% 4% 3%

SWEDEN AUSTRIA OTHER

2% 2% 14%

The biggest medtech markets in Europe are Germany, France, the

United Kingdom, Italy and Spain6. The same countries form the
26 MedTech Market in Europe top 5 IVD markets in Europe7.
EUROPEAN IVD MARKET BY COUNTRY, 2016 (REF. 7)

GERMANY ITALY FRANCE SPAIN

21% 15% 13% 9%

UK SWITZERLAND BELGIUM NETHERLANDS

9% 4% 3% 3%

POLAND AUSTRIA OTHERS

3% 2% 17%

MedTech Market in Europe 27

WORLD MEDICAL DEVICE MARKET BY REGION
BASED UPON MANUFACTURER PRICES, 2016 (REF. 6)

USA EUROPE JAPAN CHINA

43 %
29 %
7 %
6 %

CANADA BRAZIL RUSSIA OTHER

2 %
1 %
1 %
11 %

28 MedTech Market in Europe

WORLD MEDICAL TECHNOLOGY MARKET
BY AREA AND SALES GROWTH, 2016-2022 (REF. 8)

WW Market Share in 2022

18%
In Vitro
Diagnostics
16% (IVD)

14%
Diagnostic
12% imaging
Cardiology
10%

Source: Evaluate, September 2017

Ophthalmics
Drug
8% delivery
6%
Orthopedics
4%

2% General Endoscopy
& Plastic
Wound management Surgery Dental
0%
+3.0% +3.5% +4.0% +4.5% +5.0% +5.5% +6.0% +6.5% +7.0%

% Sales Growth: CAGR 2016-22

Medical technology offers solutions for many disease areas. On a worldwide perspective,
in vitro diagnostics are the largest sector, followed by cardiology and diagnostic imaging8.

Note: Size of Bubble = WW Sales in 2022 MedTech Market in Europe 29

EUROPEAN MEDICAL DEVICE MARKET GROWTH RATES,
BASED UPON MANUFACTURER PRICES, 2008-2016 (REF. 6)

15%

10%

5%

0%
2008 2009 2010 2011 2012 2013 2014 2015 2016

-5%

The European medical devices market has been growing on average by

4,4% per annum over the past 9 years. Demand fell in 2009 due to the
economic crisis, resulting in a growth rate of only 1%. The market recovered
in 2010, but growth rates fell back in 2011.

30 MedTech Market in Europe

EUROPEAN IN VITRO DIAGNOSTICS MARKET GROWTH RATES,
BASED UPON MANUFACTURER PRICES, 2008-2016 (REF. 7)

5%

4%

3%

2%

1%

0%
2008 2009 2010 2011 2012 2013 2014 2015 2016
-1%

-2%

-3%

-4%

The European IVD market growth has been slowing down until 2013, while annual
growth rates in the pre-crisis period were at around 2-4%. In 2013 the European
market started to recover and the annual growth rate in 2016 was around 1%.

* Market size estimated in manufacturers’ prices, not including

margins, such as value added in the wholesaling and retailing,
transportation costs, some taxes included in the final price, etc. MedTech Market in Europe 31
Trade in Europe
 ¤17.5 billion
Estimation of Europe’s
trade surplus in 2016

Europe has a positive medical technology trade* balance of €17.5 billion (2016)
and this represents a more than twofold increase since 2006. In comparison, the US medical
technology trade surplus is at €5 billion. Compared to 2012, the main European medtech trade
partners remain the same: the US, China and Japan (Ref 6).

*Trade section does not include in vitro diagnostics

in the figures for medical technology. Trade in Europe 33
TOP EUROPEAN MEDICAL DEVICE EXPORT DESTINATIONS, 2016 (REF. 6)

Russia
2.8%

Japan
USA
5.4%
36.9 China
10.3
India
1.9%

Brazil
1.4%

34 Trade in Europe
TOP SUPPLIERS TO EUROPEAN MEDICAL DEVICE MARKET (IMPORTS), 2016 (REF. 6)

Canada
3.0%

Japan
USA 5.0%
China
55.0 India
0,8%
10.0
Singapore
2.0%

Australia
4.0%

Trade in Europe 35
36
0
5000
10.000
15.000
20.000
25.000
MILLIONS
G
ER
M
A
N N 25.040
ET Y
H 16.439
ER
LA
N
D 15.658
S
BE 12.959
L G

Trade in Europe
IU
M 11.419
9.579
IR
EL
A
N 10.673
SW D
IT 2.045
ZE
RL
A
N 9.681
D
4.015
FR
U A
N N
IT CE 6.934
ED
9.741
KI
N
G
D
O 5.284
M
7.361

IT
A 3.494
LY
5.360
A
U
ST
RI
A 2.459
D 2.174
EN
M
A
RK 2.008
1.278
FI
N
EXPORT AND IMPORTS OF MEDICAL DEVICE BY COUNTRY 2016

LA
(INCLUDING INTRA-COMMUNITY TRADE, MILLION EUROS) (REF. 6)

N 1.573
D
809
SP
A 1.437
IN
3.942
SW
ED
EN 1.433
1.560
PO
CZ LA
N 1.299
EC D
H 1.641
RE
P U
BL 1.021
IC
972
 -4000
-2000
0%
2000
4000
6000
8000
10.000
MILLIONS
IR
EL
G A
SW R NDE
M 8.628
IT A
ZE N
N Y 8.601
ET RL
H A
N
ER D 5.566
LA
BE D N
LG S 2.698
FI IUM
N 1.840
D LA
EN N
M D 765
H A
U R
N K 730
G
CZ A
EC AU RY 379
H ST
RE RI
P A 286
TRADE, MILLION EUROS), 2016 (REF. 6)

LI UBL
TH I
U C 49
A
ES NIA
TO 46
N
LA IA
TV
IA

-61 BU
LG
-63 SL A
RI
O
-127 VE A
SW N
I
E A
-196 CR DEN
O
-203 SL ATI
O A
V
-260 RO AK
M IA
-342 PO AN
LA IA
-462 PO ND
RT
-471 G UG
RE A
E L
-604 N CE
O
RW
-1.865 IT
A
AY
LY
-2.077 U

Trade in Europe
K
MEDICAL DEVICE TRADE BALANCE BY COUNTRY (INCLUDING INTRA-COMMUNITY

-2.504 SP
A
IN

37
-2.807 FR
A
N
CE
About MedTech
Europe
MedTech Europe is the European trade association representing the medical
technology industry from diagnosis to cure. We represent In-Vitro 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 promotes a balanced policy environment that helps the medical technology
industry meet Europe’s growing healthcare needs and expectations. We also promote medical
technology’s value for Europe through our five-year industry strategy, which focuses on value-
based innovations that support more sustainable healthcare systems.

We use economic research to show the benefits of medical technology and we organise many
initiatives to explain the value we bring to Europe. We bring stakeholders together to discuss
trends, issues and opportunities. Each year we also organise the European MedTech Forum, the
largest health and industry policy conference in Europe, to engage with stakeholders on common
topics of interest.

About MedTech Europe 39

References

1 European Patent Office, MedTech Europe calculations. Medical technology as defined by World Intellectual Property Orga-
nization (based on the WIPO IPC-Technology concordance as revised in August 2014). European countries refer to EU +
Norway, Switzerland. Patents are attributed by the country of residence of the applicant.

2 EFPIA – The Pharmaceutical Industry in Figures. Key Data 2017. Europe refers to EU + Norway, Switzerland.

3 MedTech Europe calculation based on the data obtained from National Associations of 12 countries for the latest year
available. Europe refers to EU + Norway, Switzerland.

4 WHO Global Health expenditure Database, Eurostat, BMI Research, MedTech Europe calculations based on the data obtained
from National Associations of 15 countries for the latest year available.

5 BMI Research, WHO, Eurostat, EFPIA, EDMA, MedTech Europe calculations. Europe refers to EU + Norway, Switzerland.

6 BMI Research, MedTech Europe calculations. Manufacturer prices. Medical technology excluding in vitro diagnostics.

7 MedTech Europe - European IVD Market Statistics Report 2016.

8 Worldwide Medtech Sales by EvaluateMedTech® Device Area: Top 15 Categories & Total Market (2016 & 2022)-
http://info.evaluategroup.com/MTWP2017-EMF.html
© MedTech Europe, 2017
www.medtecheurope.org