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 March 2022)
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
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 expenditure on health
Total expenditure on health
per capita (Intl.$,2017)
% of GDP (2017)
Health Expenditure Profile European Countries Source: WHO 2020
Meet us at Medica in Duesseldorf (13. – 16. November 2023) – ask for an appointment!
(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
(April 23) 38 Notified Bodies in 16 countries are now accredited. Currently there are 10 each in Italy and Germany, 3 in the Netherlands; in addition, two each in Finland and Poland and one each in Belgium, Slovakia, Hungary, Norway, France, Sweden, Slovenia, Spain, Ireland, Croatia and Czech Republic . Nando database
(Dec 22) According to the Roland Berger MedTech@Hospital study, about two-thirds of German hospitals expect to close the 2022 financial year in the red. More than half also plan to invest less in medical technology.
(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
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.