Market Segmentation in Germany as a Key Success Factor for Market Entry
July 2021 – Market Segmentation in Germany – According to the Federal Ministry of Health, there are about 400,000 different medical devices in Germany. These are diagnostic devices, products for surgery, intensive care, implants, products for sterilisation but also covers and medical aids of various kinds or surgical materials and laboratory diagnostics, and many more.
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.
photographer: M. Klaas Business Lunch at home at US Commercial Consul Ken Walsh
27.02.2019 – It was a great pleasure to be invited by Fiona Evans (3rd fom left), US Consul General, and Ken Walsh (2nd from right), US Commercial Consul for few homemade chilis to a casual lunch at Ken’s residence.
new standalone UKCA mark after Brexit; current EU CE marking will still be in operation for Medical Devices and invitro diagnostic in Great Britain until June 2023
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.
In future, the IVDR will also cover high-risk products that are manufactured and used in a single health facility, as well as genetic screening and tests for predisposing patients
The European Council postpones the application of EUDAMED by two years until May 2022
the EU Council decided on 22 April 2020 that the EU MDR will be postponed until 26 May 2021 – read here!
