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.
Israel – excellent market opportunities for foreign Medical Device companies
21.11.2018 – The Israeli market is one of the largest consumers of medical technology in the Middle East. In addition, Israel gives an excellent market opportunity for foreign Medical Device companies.
Only 38.4% of the demand for medical products is produced in the domestic market; 61.6% of the demand is covered by imported goods. The main customers for medical facilities and large-scale equipment are hospitals, predominantly the 339 hospitals, of which the 44 general hospitals are mostly run by the state or charitable organisations. (more…)
16.11.2018 – New trends in Medical Technology were shown at Medica 2018 which took place from 12 -15 November in Dusseldorf – the world largest Medical Device Exhibition. This time, 5,200 exhibitors at MEDICA and 800 exhibitors at COMPAMED showed their products.
28.09.2018 – The MDR (Medical Devices Regulation) will cause great changes in the world of medical technology. The MDR has been adopted on the 5th April 2017 and will replace the MDD (Medical Devices Regulation) and AIMDD (Active Implantable Medical Devices Directive).
Arab Health – second largest Medical Technology Fair in the world
19.03.2017 – Arab Health – after Medica, the second largest Medical Technology Fair in the world. 4,400 of the world’s leading healthcare companies coming in from 70 countries. In 2017 more than 130,000 trade visitors from more than 160 countries. Klaas consulting is there every year. (more…)
SI Club Köln-Römerturm: “An oak for the 20th anniversary of SI Club Gdansk”
2016 – Our Friendship-Link “Soroptimist International Club Gdansk” celebrated its twentieth anniversary from October 7th to 9th, 2016 with 120 soroptimists from Belgium, Great Britain, Israel, Italy, Japan, Liechtenstein, Netherlands, Norway, Poland and Germany.
Meet us at Arab Health (29. January-01. February 2024) – ask for an appointment!
Latest Insights
(Jan 24) TÜV Süd BABT Unlimited is an approved UK Aproved Body (UKAB) for Part III of the UK Medical Devices Regulations 2002 for Active Implantable Medical Devices (AIMD). Manufacturers can now obtain both UKCA and CE certification from TÜV Süd at the same time.
(Jan 24) Expansion of the AOP catalogue by the GKV-Spitzenverband
(Jan 24) Eudamed: the mandatory use of the UDI/Medical Devices Registration and Certificates/Notified Bodies modules has been postponed from Q1 2026 to Q2 2029
(Jan 24) 43 Notified Bodies in 18 countries are now accredited. Currently there are 10 each in Italy and Germany, 3 in the Netherlands; in addition, two each in Finland, Poland and Czech Republic and one each in Belgium, Denmark, Hungary, Lithuania, Norway, France, Slovakia, Slovenia, Spain, Sweden,Turkey, Ireland, Croatia and Cyprus. Nando database
(Aug 23) Swissdamed (Swiss Database on Medical): ACT module, available from the beginning of 2024 for the registration of companies; registration of products via UDI module, available from summer 2024.
(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
(Dec 22) According to. MHRA (Medicines & Healthcare products Regulatory Agency), the United Kingdom will continue to recognise the CE mark for medical devices until 30 June 2024. Previously, 30.6.2023 was planned.
(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
(Nov 22) Swissmedic refers to aleaflet on the obligations for authorised representatives, importers and distributors
(June 22) studies published by the German Society for Biomedical Engineering in the VDE (VDE DGBMT)
Medical device manufacturers can apply to the Joint Federal Committee (G-BA) for the NUB and receive advice on the procedure. Rules of Procedure of the G-BA.
(April 22) Distinction between medical devices and medicinal products: Guidance document MDCG 2022 of the Medical Devices Coordination Group
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.