The European Medical

Technology Industry

– in figures / 2018

What is Medical Technology? 4

Innovation 10

Employment 14

Companies 18

Table of contents

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

Visual 1: Diversity and classification of medical technology Medical Devices In Vitro Diagnostics

6 What is Medical Technology?

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

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

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

total body scanners, ultrasounds, life-supporting machines, implantable devices such as heart

valves and pacemakers, 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.

What is Medical Technology? 7

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.

8 What is Medical Technology?

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:

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.

Annex IIList A

(e.g. ABO blood-typing)

Annex IIList B

(e.g. blood glucosemonitoring)

Devices for self-testing

(e.g. pregnancytests)

Self-declareddevices

(e.g. clinical chemistry analyser)

What is Medical Technology? 9

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:

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.

Class I

(e.g. simple bandages or wound

care products)

Class IIa

(e.g. syringes forpump infusion)

Class IIb

(e.g. anaesthesiamachines)

Class III

(e.g. pacemakers)

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

FILLED WITH EPO IN 2016

41%

59%

EU28, Norwayand Switzerland

Other countries

Innovation 11

TOP 10 TECHNICAL FIELDS IN PATENT APPLICATIONS.

NUMBER OF PATENT APPLICATIONS FILED WITH EPO, 2016 (REF. 1)

MEDICAL TECHNOLOGY

DIGITAL COMMUNICATION

COMPUTER TECHNOLOGY

ELECTRICAL MACHINERY, APPARATUS, ENERGY

TRANSPORT

MEASUREMENT

ORGANIC FINE CHEMISTRY

ENGINES, PUMPS, TURBINES

PHARMACEUTICALS

BIOTECHNOLOGY

12,263

10,915

10,657

10,293

8,402

7,442

6,301

6,189

5,754

5,744

EVOLUTION OF EUROPEAN PATENT APPLICATIONS BY TECHNICAL FIELD (REF. 1)

14.000

12.000

10.000

8.000

4.000

2.000

Medical technology

Biotechnology

Pharmaceuticals

0

2006

6.000

2007 2008 2011 2012 2013 2014 2015 20162009 2010

Innovation 13

Employment

Employment 15

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.

>675,000 employees

3

Germany

210,000UnitedKingdom

100,000Ireland

35,000

France

85,000

Switzerland

54,000

ItalySpain23,000

16 MedTech Market in Europe

TOP 7 COUNTRIES WITH HIGHEST EMPLOYMENT IN THE MEDICAL TECHNOLOGY INDUSTRY (REF. 3)

76,000

Ireland

74

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

Switzerland

64Germany

25UK

15Italy

13Netherlands

9Spain

5Greece

5Portugal

4Sweden

23Belgium

15Denmark

26France

13

Employment 17

Companies

Companies 19

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 personsand has an annual turnover not exceeding €50 million (small company- employsfewer than 50 persons and has a turnover of less than €10 million).

95% SMEs

27,000medical technology

companies in Europe

Expenditure

on Medical

Technology

Expenditure on Medical Technology 21

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).

¤203Expenditure on

medical technology

per capita in Eu-

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

In vitro diagnostics

Medical devices(incl. imaging)

6.5%

7.2%Medical technology

Phamaceuticals& other medicalnon-durables

15.9%

0.7%

Inpatient & outpatient care,other

76.9%

22 Expenditure on Medical Technology

Expenditure on Medical Technology 23

MedTech Market

in Europe

MedTech Market in Europe 25

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%).

¤110billion market

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

The biggest medtech markets in Europe are Germany, France, theUnited Kingdom, Italy and Spain6. The same countries form thetop 5 IVD markets in Europe7.

GERMANY

28%

FRANCE

15%

UK

12%

ITALY

10%

SWEDEN

2%

SWITZERLAND

4%

NETHERLANDS

4%

SPAIN

6%

BELGIUM

3%

AUSTRIA

2%

OTHER

14%

26 MedTech Market in Europe

EUROPEAN IVD MARKET BY COUNTRY, 2016 (REF. 7)

GERMANY

21%

FRANCE

13%

ITALY

15%

SPAIN

9%

SWITZERLAND

4%

BELGIUM

3%

NETHERLANDS

3%

POLAND

3%

AUSTRIA

2%

OTHERS

17%

MedTech Market in Europe 27

UK

9%

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

USA

43% 29% 7% 6%

2% 11%1% 1%

EUROPE JAPAN CHINA

CANADA BRAZIL OTHERRUSSIA

28 MedTech Market in Europe

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

Note: Size of Bubble = WW Sales in 2022

Source: Evaluate, September 2017

WW Market Share in 2022

% Sales Growth: CAGR 2016-22

2%

4%

6%

8%

10%

12%

14%

16%

18%

0%

+3.0% +3.5% +4.0% +4.5% +5.0% +5.5% +6.0% +6.5% +7.0%

Ophthalmics

Cardiology

Drugdelivery

Wound management

Orthopedics

Diagnosticimaging

DentalEndoscopy

In Vitro Diagnostics

(IVD)

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.

MedTech Market in Europe 29

General & Plastic Surgery

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

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 .

5%

10%

15%

-5%

0%

2008 2009 2010 2011 2012 2013 2014 2015 2016

30 MedTech Market in Europe

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

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 includingmargins, such as value added in the wholesaling and retailing,transportation costs, some taxes included in the final price, etc.

1%

0%

-1%

4%

3%

2%

5%

-4%

-3%

-2%

2008 2009 2010 2011 2012 2015 2016

MedTech Market in Europe 31

20142013

Trade in Europe

Trade in Europe 33

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.

¤17.5 billionEstimation of Europe’s

trade surplus in 2016

TOP EUROPEAN MEDICAL DEVICE EXPORT DESTINATIONS, 2016 (REF. 6)

USA

36.9

Brazil1.4%

India1.9%

China10.3

Russia2.8%

Japan5.4%

34 Trade in Europe

TOP SUPPLIERS TO EUROPEAN MEDICAL DEVICE MARKET (IMPORTS), 2016 (REF. 6)

USA

55.0

Canada3.0%

Australia

India0,8%

Singapore2.0%

China10.0

Japan5.0%

4.0%

Trade in Europe 35

EXPORT AND IMPORTS OF MEDICAL DEVICE BY COUNTRY 2016 (INCLUDING INTRA-COMMUNITY TRADE, MILLION EUROS) (REF. 6)

5000

10.000

15.000

20.000

25.000

0

GERMANY

25.040

16.439

15.658

12.959

11.419

9.579

10.673

2.045

4.015

2.459

9.681

7.361

5.284

5.360

3.494

6.934

NETHERLANDS

BELGIUM

IRELAND

SWITZERLAND

FRANCE

UNITED KINGDOM

AUSTRIA

DENMARK

FINLAND

SPAIN

SWEDEN

POLAND

CZECH REPUBLIC

ITALY

9.741

2.174

2.008

1.278

1.573

809 1.437

1.433

1.560

1.299

1.641

1.021

972

MILLIONS

36 Trade in Europe

3.942

MEDICAL DEVICE TRADE BALANCE BY COUNTRY (INCLUDING INTRA-COMMUNITYTRADE, MILLION EUROS), 2016 (REF. 6)

2000

4000

6000

10.000

MILLIONS

8000

-2000

-4000

0%

IRELAND

GERMANY

SWITZERLAND

NETHERLANDS

BELGIUM

FINLAND

DENMARK

HUNGARY

AUSTRIA

CZECH REPUBLIC

LITHUANIA

ESTONIA

LATVIA

ROMANIA

POLAND

PORTUGAL

GREECE

NORWAY

BULGARIA

SLOVENIA

SWEDEN

CROATIA

SLOVAKIA

ITALYUK SP

AINFRANCE

8.628

8.601

5.566

2.698

1.840

765

730

379

286

49 46

-260-61

-63

-127

-196

-203

-342

-462

-471

-604

-1.865

-2.077

-2.504

-2.807

Trade in Europe 37

About MedTech

Europe

About MedTech Europe 39

MedTech Europe is the European trade association representing the medicaltechnology 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.

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