Market Barriers to the introduction of medical devices in Germany. What could these be and how can they be overcome?
photo: iStock Market barriers to market entry in Germany for Medical Device Manufacturers
December 2020, Maria Klaas – According to a recent study from 2020 by Clairfield International, the German medical technology market is by far the largest in Europe with € 33 billion. It is therefore no wonder that small and medium-sized enterprises (SMEs) from Germany or abroad want to participate in this market.
The global market for medical technology companies – facts and figures
Juli 2020 – The global market for medical technology continues to offer great market opportunities for medical technology companies. Especially in the Middle East and Asia, the markets are growing steadily and rapidly. South America is recording double-digit growth rates, mainly due to the Mercosur free trade agreement concluded in 2019. Germany still plays the most important role in Europe. The per capita turnover is 402€, more than in any other country in the world.
There are 27,000 medtech companies in Europe, about half of which are based in Germany, followed by the UK, Ireland, Italy, Switzerland, Spain and France. Most of them are SMEs.
650,000 people work for medical technology companies in Europe, of which about 210,000 people are in Germany alone
Two of the world’s top-selling companies are based in Germany: Siemens Healthineers and Fresenius Medical Care. Three others are among the top 10 in Europe. These are Philipps in the Netherlands and Novartis and Roche in Switzerland
North America:
North America is the largest market for medical technology
Seven of the ten top-selling medical technology companies come from the USA
6,500 small and medium-sized MedTech companies are located in the USA
Approximately 520,000 people are employed by medical technology companies in the USA
The main hubs are located in California, Minnesota, Massachusetts. Florida, Indiana, Pennsylvania, Texas, New York, New Jersey and Illinois also play an important role
Asia:
Asia is the third largest market after North America and Europe. Market researchers assume that Asia will overtake Europe in 2020.
The main reason for the rapid growth in Asia is the growing middle class and the rising average age. This is expected to rise to around 600 million people by 2025.
Various funding programmes are providing massive support for technical developments in Asian countries, for example in Singapore and China.
Rest of the world:
Asia, Latin America and the Middle East show the greatest growth potential for medical products
The MedTech market is growing enormously, especially in the Middle East
Double-digit growth rates are predicted in emerging markets such as Mexico, Malaysia and Brazil
Brazil is one of the fastest growing markets in the world. In recent years, imports have grown by around 26% annually. This can be explained by the free trade agreement Mercosur, which was concluded in 2019 and will continue to facilitate the export of MedTech products to South America.
Source: Marktstudie Medizintechnik 2020, Luther.Clairfield International
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April 2020 by Maria Klaas – With 67 million inhabitants, France is the second largest market in Europe after Germany. And this also applies to the Medical Device sector. Therefore, medical device manufacturers from all over the world would like to place their products here as well. But how can a successful market entry take place?
The new Medical Devices Regulations (MDR) – what you need to know!
photo: iStock CE mark according to MDR
The new Medical Devices Regulations (MDR) and the Active Implantable Medical Devices Directive (AIMDD) were published in May 2017. Its transitional period will end on 26 May 2020. From that date the MDR will apply fully.
August 2019 – Transforming the MedTech Industry – why is that the future?
According to a commissioned study of the United Nations, the world population will increase to 10 billion by 2050. 2 out of 5 people will be over 60 years old and 434 million over 80.
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Latest Insights
(Dec 24) Number of hospital treatments in Germany increased by 2.4% to 17.2 million in 2023. Nevertheless, not yet at the pre-corona level of 2019 of 19.4 million (according to the Federal Statistical Office). Read more about the QB Analyser. It can tell you in which hospitals the treatments take place.
(Dec 24) India: according to an E&A analysis, the medtech market is expected to grow from USD 12 billion in 2023/24 to USD 50 billion by 2030. India will remain heavily dependent on imports. In 2023/24, approx. 85% was sourced from abroad. Germany accounted for 11%. Market entry India: read here.
(Aug 24) 48 Notified Bodies in 18 countries are now accredited. Currently there are 10 each in Italy and Germany, 3 in the Netherlands; in addition, two each in Finland, Poland and Czech Republic and one each in Belgium, Denmark, Hungary, Lithuania, Norway, Slovakia, Slovenia, Spain, Sweden,Turkey, Ireland, Croatia and Cyprus. Nando database. GMED SAS from France, Paris is no longer a Notified Body
(Aug 24) Roland Berger Hospital Study 2024 in Germany. Larger hospitals expect a positive development in the coming years. Smaller hospitals are rather pessimistic about the future. According to the study, mergers could be a solution. (in German)
(July 24) New MDCG guideline on the clinical evaluation of orphan devices
(July 24) According to the current Hospital Rating Report 2024, 10% of hospitals are in the "red zone" with an increased risk of insolvency.
(June 24) According to the spring survey of the Hospital Index of the German Hospital Institute (DKI) (in German) 61% of German general hospitals rate their current economic situation as poor (40%) or very poor (21%). The reason for this is the forthcoming Hospital Care Improvement Act (KHVVG)
(Jan 24) TÜV Süd BABT Unlimited is an approved UK Aproved Body (UKAB) for Part III of the UK Medical Devices Regulations 2002 for Active Implantable Medical Devices (AIMD). Manufacturers can now obtain both UKCA and CE certification from TÜV Süd at the lysame time.
(Jan 24) Expansion of the AOP catalogue by the GKV-Spitzenverband
(Jan 24) Eudamed: the mandatory use of the UDI/Medical Devices Registration and Certificates/Notified Bodies modules has been postponed from Q1 2026 to Q2 2029
(Aug 23) Swissdamed (Swiss Database on Medical): ACT module, available from the beginning of 2024 for the registration of companies; registration of products via UDI module, available from summer 2024.
(May 23) Great Britain decides to extend the deadline for CE marking of medical devices according to MDR. From July 2025, the new legal framework is to apply
(Dec 22) According to. MHRA (Medicines & Healthcare products Regulatory Agency), the United Kingdom will continue to recognise the CE mark for medical devices until 30 June 2024. Previously, 30.6.2023 was planned.
(Nov 22) According to the Roland Berger study "Global MedTech-How to succeed in uncertain times", the medical technology industry is struggling with high energy costs, rising inflation and supply chain problems. Solutions are offered by digitalisation, more benefit-based billing models and the shift towards personalised medicine.
(Nov 22) Facts&Figures 2022 from MedTech Europe, the European trade association for the medical technology industry
(Nov 22) New MDCG document on requirements for Notified Bodies - in the context of the MDR as well as IVDR
(Nov 22) Swissmedic refers to aleaflet on the obligations for authorised representatives, importers and distributors
(June 22) studies published by the German Society for Biomedical Engineering in the VDE (VDE DGBMT)
Medical device manufacturers can apply to the Joint Federal Committee (G-BA) for the NUB and receive advice on the procedure. Rules of Procedure of the G-BA.
(April 22) Distinction between medical devices and medicinal products: Guidance document MDCG 2022 of the Medical Devices Coordination Group
Internet platform for medical needs in Ukraine by the German initiative Medical Bridge.eu
European industry association for digital assistive technology DATEurope founded in early 2021. DAT includes aids for communication, for the blind and visually impaired, for environmental control, assistive call systems, software tools and robotics.
