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Boost your business in Europe – Find your European consultancy for medical devices.

The European medical devices market is the second largest in the world, preceded by the U.S. and followed by Japan. According to a report by the International Trade Administration (US Department of Commerce), the European medical devices market is expected to continue its expansion and grow by 9% every year.

The total European medical devices markets are estimated at 95 Bill. EUR. The leading EU markets are Germany, France, Italy, United Kingdom and Spain.

The European Union embraces a unique patchwork of markets, systems, regulations and mentalities, but also presents challenges and possibilities for the exporters of medical devices. A suitable consultancy firm with expertise in the medical devices sector is the key to your success

Covid-19 worth knowing (Germany)

  • As of 12.4.21, the BfArM has granted special approvals to 35 antigen tests for self-testing by non-professionals.
  • Stiftung Warentest tested 10 FFP2 masks. The test winner was the Aura 9320+ mask from 3M.
  • EU Commission has created the possibility for Notified Bodies to carry out virtual audits in individual cases. Notice.
  • Recommendations of the GKV-Spitzenverband to ensure the supply of medical aids during the spread of the coronavirus SARS-CoV2, valid until 31 March 2021
  • from 1.10.2020 only FFP2 and FFP3 masks with a CE mark may be sold in Europe (according to Dekra)
  • the Federal Ministry of Economics has launched a matching platform for protective equipment (PPE) (MAPS)
  • to recognise a good FFP2 mask
  • new general ruling on hand disinfectants issued by the Federal Institute for Occupational Safety and Health (BAuA)
  • EU response to the coronavirus – strategic rescEU medical stockpile for ventilators, PPE products, vaccines et al hosted by 6 EU member states: Denmark, Germany, Greece, Hungary, Romania, Sweden
  • Portal with PPE providers in Berlin and Brandenburg
  • German register for outpatient intensive care
  • New guideline for the funding of projects on the “Prevention and treatment of epidemic infections with innovative medical technology” from the German Federal Ministry of Education and Research, published on 3 August 2020
  • EU Commission extends customs and VAT exemption on the import of medical devices and protective equipment (PPE) from third countries until the end of April 2021
  • The European Commission demands preferential certification of coronary medical devices by Notified Bodies and publishes a new “Covi-19 list of essential medical devices (MDs and IVDs)”
  • Information from BfArM on the use of mouth-nose covers, medical face masks and particle-filtering half masks – intended use, classification as medical device or protective equipment, the testing and certification and protective effect
  • Application portal for the fast track procedure of Medical Apps of the BfArM. More info.
  • The German Federal Institute for Drugs and Medical Devices (BfArM) has updated the instructions for manufacturers, importers and distributors for the special approval of medical mouth and nose protection (MNS) and filtrating half masks (FFP2 and FFP3). According to BfArM, there is currently no longer a supply bottleneck for these products in the current SARS-CoV-2 pandemic situation. Therefore, the special approval was adjusted accordingly. Read more (status Sept. 2020)
  • The Federal Ministry of Health (BMG) published a Sars-CoV-2 Drug Regulation on April 21, 2020. Also affected are specifications for medical devices in the context of the corona epidemic.
  • Europe Acts initiated Europe vs Covid-19, a free, Europe-wide platform for companies and hospitals offering or requesting medical products
  • GHX offers a free supplier list for healthcare providers – for face and eye protection, respiratory protection mask, surgical masks, hygiene supplies, disinfectants, disposable garments, cannulas, respiratory equipment, disposable gloves, protective covers for couches

Healthcare statistics of selected EU countries.

The medical devices markets of Germany, United Kingdom, France, Italy and Spain are the largest in Europe. Some of the best-known medical device manufacturers are based in these G5 countries and some major players from around the world have operations here. Nevertheless, small-to mid-sized medical device companies make up the majority of the industry.

       Total population    Total expenditure on health Total expenditure on health 
 2017 per capita (Intl.$,2017) % of GDP (2017)
 Czech Republic10,578,8201,4767.2
 United Kingdom


Health Expenditure Profile
European Countries
Source: WHO 2020

Efficient clinic targeting with the QB-Analyzer

Online tool for quick and easy determination of market potential in the German hospital market. Suitable for marketing analysis and sales control.
•    analysis of data with diagrams and corresponding diagrams
•    select ICD-Codes and OPS-Procedures and visualize them on the map
•    group regional data into clusters
•    export the results of the analyzes and illustrate them in reports
With current data of the year 2021.

Contact us.

Find your way in the health market jungle – Klaas consulting – your medical device consultancy

According to your requirements, we offer you a tailor-made service package to enable your smooth and efficient entry onto the market in European countries