European

IVD Market
Statistics
Report
2022
MEDTECH EUROPE – EUROPEAN IVD MARKET STATISTICS REPORT 2022

Overview The European IVD Market

MedTech Europe is pleased to publish the market estimates of the In vitro diagnostic (IVD)
industry in Europe. The MedTech Europe figures include market size and dynamics information,
based on 2021 and 2020 data. Macroeconomic and healthcare data are also included for the

41,2%
EU27-member states plus the European Free Trade Association members (EFTA) –Switzerland, 25,000 45%
Norway and Iceland, and Switzerland, as well as for the United Kingdom and Turkey.
40%

20.670
In vitro diagnostics (IVDs) are an essential part of today’s healthcare. Results of in vitro
testing influence as many as 70% of clinical decisions, while IVDs account for just
1% of total healthcare expenditure in the EU-27, UK and EFTA. They play a vital role in 35%
20,000

29,1%
in the response to COVID-19. A critical element for combatting the COVID-19 pandemic is
to have suitable diagnostic tests available. Furthermore, IVDs are used to diagnose, monitor, 30%
screen and assess predispositions to diseases, thereby contributing to the available medical

14.384
information regarding a patient. By allowing earlier and more targeted treatments, IVDs help 25%
to reduce hospital stays and convalescences, resulting in healthier populations, reduced costs, 15,000
and economic growth in the long run.
20%

11.145
11.102
10.943

10.965
10.736

10.758
10.603

10.580
10.549
Since 2013, the IVD market has been stagnant with slight growth. In 2020, however, due
to the COVID-19 pandemic and the high demands for SARS-Cov-2 testing, the IVD market 15%
has experienced an increase of + 25,4%. In 2021, we witness an unprecedented record 10,000
growth of 41.2%. Overall revenues across EU-27, UK and EFTA reached €20,670 million. 10%
When looking beyond the COVID-19 related diagnostics and comparing to 2020, there have
been clear signs of recovery in most tests in the other IVD segments such as clinical chemistry,

1,9%
1,5%
5%

1,2%
0,9%

0,3%

0,4%
0,2%
immunology, and haematology across the countries.

-0,5%
5,000

-3,1%
0%

The differences in total healthcare expenditure, both in relative terms to GDP and absolute
amounts, demonstrate the wide variation in access to healthcare across the thirty-one countries -5%
in this report. Relative to GDP Germany is the leading country at 13.2%, followed by the UK,
Austria, Switzerland and Sweden. In absolute amounts the healthcare expenditure per capita 0 -10%
Switzerland is in first position, followed by Germany, Austria, Slovakia, Denmark, Norway and 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
Iceland. The IVD per capita expenditure also shows a wide variation from a low of €7.2 in
Bulgaria to €88.9 in Switzerland, which remains also the leading country.
Revenues (million €) Growth Rate

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MEDTECH EUROPE – EUROPEAN IVD MARKET STATISTICS REPORT 2022

IVD Market Statistics

THE 2021 IVD market IVD IVD mkt The applied exchange rates are the 2021 annual average exchange rates
Population GDP / capita THE / THE as % IVD mkt. IVD mkt.
GDP 2021 (or latest growth market / / capita published by The European Central Bank. Applying a single exchange rate
2021 2021 capita GDP 2021 2020
availiable) rate 21-20 THE 2021 2021
Countries to both 2021 and 2020 sales data eliminates possible fluctuations of market
1000 Mio € € Mio € € % Mio € Mio € %  % €
size and market growth due to exchange variations. The impact of these
Source: Eurostat Source: OECD Source MedTech Europe
fluctuations is shown in the table below. During the collection of 2021
Germany 83.155 3.601.750 43.290 457.232 5.499 12,7% 6.301 3.051 106,5% 1,4% 75,8
year’s figures, the 2020 market size was re-estimated at the same time.
France1 67.657 2.500.870 36.660 307.785 4.549 11,2% 2.610 2.140 22,0% 0,8% 38,6
That, together with the use of a single exchange rate, explains why some
Italy 59.236 1.782.050 30.150 167.855 2.834 9,4% 2.071 1.780 16,3% 1,2% 35,0
countries show different revenues compared to the figures presented in
Spain 47.399 1.206.842 25.500 120.203 2.536 10,0% 1.727 1.514 14,1% 1,4% 36,4
last year’s report for 2020. The growth rate between 2021 and 2020 has
Netherlands 17.475 856.356 48.840 96.498 5.522 10,4% 504 365 38,2% 0,5% 28,8
been calculated using the re-estimated figures. The 2021 data regarding
Greece 10.679 181.675 17.010 15.720 1.472 8,7% 412 254 62,1% 2,6% 38,6
population and GDP are the latest available from Eurostat. The figures
Portugal 10.298 214.471 20.840 23.686 2.300 11,0% 491 401 22,6% 2,1% 47,7
regarding healthcare expenditure are the latest available from OECD.
Belgium 11.555 502.312 43.340 49.293 4.266 9,8% 428 372 14,8% 0,9% 37,0
Sweden 10.379 537.310 51.590 60.669 5.845 11,3% 253 239 5,7% 0,4% 24,4
Austria 8.933 406.149 45.370 49.024 5.488 12,1% 568 480 18,3% 1,2% 63,6
Denmark 5.840 336.719 57.520 36.411 6.235 10,8% 333 175 90,1% 0,9% 57,0
IVD Market Size in EUR
Finland 5.534 251.367 45.360 22.685 4.099 9,0% 159 132 20,7% 0,7% 28,7
Ireland 5.006 426.283 84.940 28.361 5.665 6,7% 232 151 53,6% 0,8% 46,3
(using actual exchange rates)
Luxembourg 635 72.295 112.780 3.683 5.802 5,1% 30 21 45,0% 0,8% 48,0
Poland 37.840 574.772 15.060 37.879 1.001 6,6% 493 442 11,6% 1,3% 13,0 IVD
2021 2020 IVD IVD IVD IVD market
Romania 19.202 240.154 12.560 13.496 703 5,6% 240 218 10,0% 1,8% 12,5
Exchange Exchange market market market market growth
Czechia 10.702 238.238 22.270 20.526 1.918 8,6% 267 178 49,5% 1,3% 24,9 Country Currency Rate Rate 2021 2020 2021 2020 rate
21-20
Hungary 9.731 153.759 15.840 9.766 1.004 6,4% 107 81 32,6% 1,1% 11,0
Average Average Mio LC Mio LC Mio € Mio € %
Bulgaria 6.917 71.077 10.330 5.211 753 7,3% 50 35 41,1% 1,0% 7,2
Poland PLN 0,2191 0,2252 2.249 2.015 493 454 8,6%
Slovakia 5.460 98.523 18.110 6.686 1.225 6,8% 335 97 244,9% 5,0% 61,3
Romania RON 0,2032 0,2067 1.181 1.054 240 218 10,2%
Croatia 4.036 58.254 15.020 3.901 967 6,7% 83 67 25,0% 2,1% 20,7
Lithuania 2.796 56.179 20.000 4.349 1.555 7,7% 58 37 55,8% 1,3% 20,6 Czech Rep CZK 0,03901 0,03783 6.837 4.574 267 173 54,1%

Latvia 1.893 33.696 17.890 2.168 1.145 6,4% 49 36 37,7% 2,3% 25,9 Hungary HUF 0,00279 0,002849 38.392 29.106 107 83 29,2%
Slovenia 2.109 52.208 24.770 4.762 2.258 8,6% 100 62 60,8% 2,1% 47,3 EU27 EUR N/A 17.963 12.379 45,1%
Estonia 1.330 31.445 22.580 2.289 1.721 7,3% 40 26 51,5% 1,7% 30,1
UK GBP 1,1622 1,1248 1.401 1.135 1.628 1.277 27,5%
Cyprus 896 24.019 26.680 1.750 1.953 7,3% 15 10 45,0% 0,9% 16,9
TOTAL
Malta 516 14.681 28.310 1.255 2.432 8,5% 8 6 45,0% 0,6% 15,5 (EU27, EUR N/A 20.670 14.350 44,0%
17.963 45,2% EFTA,UK)
EU27 447.207 14.523.453 912.610 1.553.143 80.747 10,5% 12.370 1,2% 40,2
Switzerland 8.670 676.775 77.750 77.187 8.903 11,4% 771 514 49,9% 1,0% 88,9 Turkey TRL 0,09748 0,12623 7.307 5.094 712 643 10,8%

Norway 5.391 407.533 75.360 41.120 7.627 10,1% 290 168 72,7% 0,7% 53,8 TOTAL
(EU27,
Iceland 369 21.653 58.130 2.079 5.638 9,6% 18 12 47,3% 0,9% 48,3 EUR N/A 21.383 14.993 42,6%
EFTA, UK,
EFTA 14.430 1.105.962 211.240 120.387 22.168 10,9% 1.079 694 55,4% 0,9% 74,7 Turkey)
UK2 67.281 2.555.065 37.976 321.505 4.779 12,6% 1.628 1.319 23,4% 0,5% 24,2
TOTAL (EU27, EFTA,UK) 528.919 18.184.480 1.161.826 1.995.036 107.693 10,8% 20.670 14.384 43,7% 1,0% 39,1
1) France data includes only the Central Laboratory IVD Market.
Turkey 83.614 689.547 8.247 22.719 272 3,3% 712 497 43,4% 3,1% 8,5

TOTAL (EU27, EFTA,

2) UK data reflects the consolidated sales of the participating companies
612.533 18.874.026 1.170.073 2.017.755 107.965 10,5% 21.382 14.880 43,7% 1,1% 34,9 in GDMS, plus the figures published by NHS England for glucose test
UK,Turkey)
strip sales adjusted to represent the whole of the UK.

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 MEDTECH EUROPE – EUROPEAN IVD MARKET STATISTICS REPORT 2022

IVD Market Size 2021 (million EUR) IVD Market per Capita 2021 (EUR)

Germany 6,301 Switzerland 88,9

France 2,610 Germany 75,8
Italy 2,071 Austria 63,6
Spain 1,727 Slovakia 61,3
UK 1,628 Denmark 57,0
Switzerland 771 Norway 53,8

Turkey 712 Iceland 48,3

Austria 568 Luxembourg 48,0

Netherlands 504 Portugal 47,7

Poland 493 Slovenia 47,3

Portugal 491
Ireland 46,3

Belgium 428
EU27 39,9
France 38,6
Greece 412
Greece 38,6
Slovakia 335
Belgium 37,0
Denmark 333
Spain 36,4
Norway 290
Italy 35,0
Czechia 267
Estonia 30,1
Sweden 253
Netherlands 28,8
Romania 240
Finland 28,7
Ireland 232
Latvia 25,9
Finland 159
Czechia 24,9
Hungary 107
Sweden 24,4
Slovenia 100
UK 24,2
Croatia 83
Croatia 20,7
Lithuania 58
Lithuania 20,6
Bulgaria 50
Cyprus 16,9
Latvia 49 Malta 15,5
Estonia 40 Poland 13,0
Luxembourg 30 Romania 12,5
Iceland 18 Hungary 11,0
Cyprus 15 Turkey 8,5

100,00
20,00

40,00

60,00

80,00
1,000

2,000

3,000

4,000

5,000

6,000

7,000

Malta 8 Bulgaria 7,2

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MEDTECH EUROPE – EUROPEAN IVD MARKET STATISTICS REPORT 2022

SARS-Cov-2 Tests: Volumes

ITALY IVD MARKET 2,071 mEUR +16.3%

“The IVD Italian market, in 2021 recorded an increase of 16.3%. The growth, for
Country Total Tests 2021 Total Tests 2020 Growth rate 21-20
almost the totality, is to be attributed to the COVID-19 diagnostics. Looking at
the market data, excluding COVID-19 diagnostics and glucose tests, we record
Source: ECDC; *Our World in Data an even higher growth of 19.4%. In addition to the increase in COVID-19 related
United Kingdom* 343.554.199 48.972.436 602% turnover, this market growth is due to the the gradual reopening of all health
France 148.436.784 33.651.450 341% services which allowed Laboratory Diagnostics to resume its normal activities
Austria 115.889.875 3.747.074 2993% (hospital and territorial) after almost a year of total closure. In addition, in 2021,
Italy 114.406.110 20.887.600 448% laboratory activities began to recover the enormous accumulation of health services
Greece 104.759.764 3.432.711 2952%
not provided in the previous year. The latter will certainly further affect overall
Denmark 95.106.382 10.576.739 799%
growth. The year 2020 is certainly not comparable with any other year. The serious
Turkey* 94.520.585 24.464.277 286%
economic crisis due to the almost total closure of all activities, has in fact generated,
in 2021, a “rebound effect” that has led to the results achieved. If we compare
Germany 57.414.318 36.088.129 59%
the results of 2021 to 2019 (pre-pandemic), the overall result (excluding COVID-19
Spain 46.894.218 21.486.152 118%
diagnostics) would certainly be more truthful than the country system and in this
Czechia 41.832.831 4.736.765 783%
specific case of Laboratory Diagnostics (+1.7%).“
Netherlands 29.968.706 8.372.650 258%
Portugal 20.937.405 5.724.026 266%
Confindustria Dispositivi Medici, Italian IVD industry association
Poland 20.019.974 7.886.328 154%
Cyprus 16.727.060 939.253 1681%
Romania 12.391.363 1.940.112 539%
Slovenia 12.068.113 755.813 1497%
Switzerland* 11.090.167 3.288.431 237%
Slovakia 11.053.154 1.256.833 779%
Sweden 10.737.369 4.093.604 162%
Norway 10.052.849 3.069.032 228% UNITED KINGDOM IVD MARKET 1,628 mEUR +23.4%
Ireland 7.625.591 2.472.349 208%
Belgium 6.324.519 7.010.457 -10% “In the UK, dramatic reductions in non-Covid testing activity were evidenced in
Bulgaria 6.276.243 1.093.797 474% 2020 by reductions in revenue, such as -20% for Clinical Chemistry excluding
Finland 6.255.010 2.512.145 149% Rapid Tests, this activity has recovered significantly in 2021 (+20%). Nucleic Acid
Croatia 5.194.645 1.084.453 379% Testing and Immunoassay are strongly boosted by Coronavirus testing, as is Rapid
Lithuania 2.916.002 1.577.134 85% Testing (mainly antigen tests for current infection). Coronavirus testing has grown
Hungary 2.798.321 1.799.526 56%
from zero in 2019 to almost one quarter of the total UK IVD market in 2021,
Luxembourg 2.168.275 1.656.550 31%
without counting non-participant company supply via government contracts, for
Estonia 1.881.816 550.121 242%
which we have no reliable estimates. Core laboratory reagents, instruments &
consumables market revenues recovered a further £66m (+16%). Microbiology
Latvia 1.114.303 475.460 134%
revenues decreased by £12m. The decrease was due mainly to a drop of -£11m
Malta 1.023.883 527.375 94%
due to transport media, as PCR testing requirements stabilised.”
Iceland 944.683 429.819 120%
Total 1.362.384.517 266.558.601 411%
BIVDA, British IVD industry association

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MEDTECH EUROPE – EUROPEAN IVD MARKET STATISTICS REPORT 2022

GERMANY IVD MARKET 6,301 mEUR +106.5% BELGIUM IVD MARKET 428 mEUR +14.8%

“For the second time in a row, the German IVD market has reached record volumes. The “The IVD market in Belgium reached 428 million EUR with a growth of 14.8%
background is the ongoing COVID-19 pandemic. Comprehensive testing is a central compared to 2020. In 2021, the expenses in the hospitals and ambulant setting have
component of the German government’s health policy strategy to combat the pandemic and increased vs. 2020 (in 2020 Covid had a major impact) with more hospitalisations and
protect vulnerable groups from infection. In this respect, the German IVD market has become consultations, therefore more IVD tests were done.”
to a large extent a political market in 2021.
beMedTech, Belgian IVD industry association.
The IVD market in 2021 is estimated to have a total volume of 6.3 billion euros. Of this, 4.1
billion euros (65 %) will be accounted for by Coronavirus testing and 2.2 billion euros (35 %)
by other diagnostics.

The market volume doubled compared to 2020 (+106.5 %). While growth for all Coronavirus
testing was extremely dynamic (+367 %), other diagnostics developed flat (+1.2 %). The
biggest growth driver in 2021 was Coronavirus rapid testing. With a volume of €3.67 billion,
PORTUGAL IVD MARKET 491 mEUR +22.6%
this market segment alone is significantly larger than the entire pre-pandemic IVD market. As
a result of the slowdown in infections, declining trends for 2022 are already clearly discernible.
“COVID-19 had a big impact on the IVD market, according to our estimation the Sars-
In non-Covid diagnostics, the area of clinical chemistry has recovered. The same applies to
CoV-2 reagents represented around 45% of the total IVD sales in Portugal in 2021. In
haematology/histology/ cytology. Microbiology, on the other hand, recorded market declines
2020, the country focus was on the COVID-19 pandemic, and we had a decrease on
for the second time in a row. The development of blood glucose self-testing is also dampening.
the routine testing with around -8%. In 2021, mainly during the second half of the
This market lost 7.2 per cent compared to the previous year, but the decline in sales has slowed
year, the routine lab testing recovered, and the patients had the possibility to start
down. The shift to sensor-based measurement systems continues to play a decisive role here.”
again visits to the health institutions. The focus of care was not only COVID-19 and due
to this fact, the turnover for the other IVD segments was aligned with 2019 figures.”
VDGH, German IVD industry association
APIFARMA, Portuguese IVD industry association

FRANCE IVD MARKET 2,610 mEUR +22%

POLAND IVD MARKET 493 mEUR +11.6%
“The Central Laboratory IVD French market (excluding diabetes) is estimated at 2,610 million
Euro, with a growth of +22% compared to 2020. This increase (14.4%) is driven by SARS- “The year 2020 was a critical one for the Polish healthcare system. Closing hospital wards,
CoV-2 products and to recovery of pre-Covid lab activity (+7.6%).” postponing treatments, and creating more beds for COVID-19 patients was pivotal. In
2021, the pandemic is slowly being brought under control and delays in overdue
SIDIV, French IVD industry association services are being compensated. Market increase has been shown in clinical chemistry,
immunology, haematology and microbiology. Virology research is at its peak in 2021.”

MedTech Polska, Polish IVD industry association

5
MEDTECH EUROPE – EUROPEAN IVD MARKET STATISTICS REPORT 2022

SPAIN IVD MARKET 1,727 mEUR +14.1% GREECE IVD MARKET 412 mEUR +62.1%

“In 2021, the Spanish market is still under the strong influence of COVID-19 and the related “After a substantial decrease in GDP in 2020 due to the COVID-19 pandemic (-9.0 %
tests. Development of biomarkers and molecular test (not only PCR) for other parameters based on latest data), in 2021 Greece is again on a growth trajectory, with a +8.3%
has also been observed. The centralisation trend for public and private labs remains high increase in GDP year-on-year. In 2021, the total IVD Market grew by 62.1% compared
but there is not a lot of room for further centralisation. Furthermore, big tenders covering to 2019, mainly driven by SARS-CoV-2 revenues of 180M Euro compared to 50M Euro
whole region and centralised per provinces and with very long execution periods superior to in 2020. The Greek IVD Market, excluding coronavirus testing, grew by 13.7%, driven
six years has been registered. Declining or stagnating point of care testing is seen due to the by growth across all the traditional IVD categories - clinical chemistry, haematology,
lack of reimbursement except for diabetes testing. In certain cases, type 2 insulin dependent immunology excluding coronavirus testing. “
patients could be candidates for continuous glucose monitoring. We witness that robotisation
is reaching not only the very big labs but also many medium size ones. SEIV, Greek IVD industry association.

IVDs are now recognized as a key player in medicine both for public and politicians. There has
been major investment in human resources and instrumentation in most laboratories but there
is uncertainty regarding the future of IVD market once the pandemic is now under control.
The best perception of added value is of microbiology and anatomic pathology departments
contribution.”
CZECH REPUBLIC IVD MARKET 267 mEUR +49.5%
FENIN, Spanish IVD industry association
“The market growth observed in 2021 in the Czech Republic has been driven by
infectious disease testing +39.8%, due to the COVID-19 pandemic, as well as related
increased revenues in services +15,6% and instruments +2.4% compared to 2020.
Furthermore, market recovery is shown also in in microbiology 14%, clinical chemistry
6.3%, and haematology 8.1% segments.”

CZEDMA, Czech IVD industry association.

AUSTRIA IVD MARKET 568 mEUR +18.3%

“The market dynamic, in 2021, was again determined mostly by SARS-CoV-2 Testing (PCR
and Antigen testing) due to the very extensive testing strategy by the government. Many
SWITZERLAND IVD MARKET 771 mEUR +49.9%
companies, not participating to the market statistics programmes entered the market. Thus,
making it difficult to estimate the total COVID-19 related market. The classical laboratory
“After a negative growth (-3.7%) of the IVD market excluding SARS-COV-2 testing in
market recovered and went basically back to the pre-pandemic level with a small increase. “
2020 vs 2019, we observed a recovery in 2021 with a growth of 6.5%. All Coronavirus
testing experienced strong expected growth of almost 50% vs. 2020.”
AUSTROMED, Austrian IVD industry association
SVDI, Swiss IVD industry Association.

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MEDTECH EUROPE – EUROPEAN IVD MARKET STATISTICS REPORT 2022

Data Gathering About In Vitro Diagnostics

The results presented above are based on individual 2021 estimates made for 27 countries, In vitro diagnostics are non-invasive tests performed on biological samples (for example blood,
comprising of the EU countries, EFTA countries, the UK and Turkey: urine or tissues) to diagnose or exclude a disease. IVDs provide valuable information about
how the body is functioning and its state of health. They are used for diagnosis, prognosis,
• 13 countries are participating in the Global Diagnostic Market Statistics (GDMS, former EDMS) risk stratification, screening and therapeutic monitoring of diseases. IVDs have a broad scope
programme: Austria, Belgium, Czech Republic, France, Germany, Italy, the Netherlands, ranging from sophisticated technologies performed in clinical laboratories to simple self-tests,
Poland, Portugal, Slovakia, Spain, Switzerland, and the UK. such as those for pregnancy and glucose monitoring.

• The National Association Members of MedTech Europe and the MedTech Europe’s Market
Research Committee have estimated the IVD market in 18 other countries not participating in About MedTech Europe
the GDMS programme: Bulgaria, Croatia, Cyprus, Denmark, Estonia, Finland, Greece, Hungary,
Iceland, Ireland, Latvia, Lithuania, Malta, Norway, Romania, Slovenia, Sweden, and Turkey. MedTech Europe is the European trade association for the medical technology industry
including diagnostics, medical devices and digital health. Our members are national, European
The figures per country are compiled from the Global Diagnostic Market Statistics (GDMS) and multinational companies as well as a network of national medical technology associations
programme, through which companies report invoiced sales of reagents, instruments and who research, develop, manufacture, distribute and supply health-related technologies,
consumables to an independent auditor, CIP, as based on the Global IVD Classification (GIVD). services and solutions. MedTech Europe’s mission is to make innovative medical technology
This is done in association with the MedTech Europe’s Market Research Committee and the available to more people, while helping healthcare systems move towards a sustainable path.
National Association Members. Although most of the molecular tests for Coronavirus have MedTech Europe encourages policies that help the medical technology industry meet Europe’s
been captured in the programmes as they are supplied by participating companies, there are growing healthcare needs and expectations. It also promotes medical technology’s value for
revenues on Rapid Tests purchased directly through national government arrangements from Europe focusing on innovation and stakeholder relations, using economic research and data,
non-participant companies which might not be all captured in this report. communications, industry events and training sessions.
More than 85% of the market is covered in major countries by GDMS, ensuring the reliability
and objectiveness of the information provided by MedTech Europe and its members. MedTech The European in vitro diagnostic industry is driven by research and development. Almost 95%
Europe encourages all IVD suppliers and countries to participate in the GDMS programme, which of the industry is comprised of small and medium size enterprises and approximately 1 billion
is the largest In vitro diagnostic audit in Europe and the most accurate source of information for euros per year is reinvested in R&D. Developed by MedTech Europe, the Global Diagnostic
understanding and predicting market trends. Market Statistics (GDMS) and Management Information System (MIS) programmes provide
a comprehensive overview of the latest market trends based on the Global IVD Product
Classification (GIVD).

For more information

Teodora Angelova
Senior Manager Market Data
Email: t.angelova@medtecheurope.org
Phone: +32 2 777 02 74