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!
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.
Efficiency increase of the strategic distribution of medical devices in Europe for SMEs
Juli 2019 – Many medical device companies aim to sell their products on European markets. Their own budget bottlenecks allow only limited market opportunities. What are the reasons and what considerations should SMEs make to increase the efficiency of the strategic distribution of their medical devices?
(Dec 22) 36 Notified Bodies are now accredited. Currently there are 10 in Italy, 3 in the Netherlands and 8 in Germany; 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.