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?
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?
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.
Overview of all assessments of new examination and treatment methods (NUB) by the G-BA
22 Notified Bodies are now accredited. Currently (August 21) there are 4 in Italy, 2 in Finland, 3 in the Netherlands and 6 in Germany; in addition, one each in Slovakia, Hungary, Norway, France, Sweden, Ireland and Croatia. Nando database
the MHRA in the UK has published a guidance document for manufacturers and distributors of medical devices
On 1 July 20, the Swiss Federal Council adopted the revision of the Regulation on Medical Devices (MepV) and the new Regulation on Clinical Trials for Medical Devices (KlinV-Mep). As a result, Switzerland remains subject to EU medical device law.