Medical Devices Regulations (MDR)

The new Medical Devices Regulations (MDR) – what you need to know!

the new Medical Devices Regulations (MDR), which must be fulfilled for CE certification as of May 2020
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.


Transforming the MedTech Industry

Transforming the MedTech Industry

transforming the MedTech Industry
Health Information Technology (HIT)
Internet of Medical Things (IoMT)
picture: IStock
Digitization of Medical Healthcare

August 2019 – Transforming the MedTech Industry – why is that the future?

According to a commissioned study of the United Nations, the world population will increase to 10 billion by 2050. 2 out of 5 people will be over 60 years old and 434 million over 80.


Strategic distribution of medical devices in Europe

Efficiency increase of the strategic distribution of medical devices in Europe for SMEs

strategic distribution medical devices in Europe
photo: iStock
Strategic Sales of Medical Devices

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?


Germany’s Medical Technology No. 1 in Europe

Germany’s Medical Technology Industry Still No. 1 in Europe

Medical Technology companies from Germany are participating at Medica Fair
photographer: M. Klaas
German MD companies at Medica

24.06.2019 – In 2015, EUR 32.39 billion was generated with medical devices in Germany. Thus Germany’s Medical Technology is clearly No. 1 with 34% of the total European sales of EUR 95 billion.


QB-Analyzer – analysis of the German hospital market

QB-Analyzer: Your online tool for the targeted analysis of the German hospital market 

Marketing and Sales Tool

The QB-Analyzer analyzes and digitizes „annually“ all data of the quality reports of German hospitals. Therefore, it is interactive and web-based.

As a result, ideal for identifying market potential and efficiently managing sales. In other words, it is an online tool for the targeted analysis of the German hospital market.

The QB-Analyzer provides you perfect graphical representations of the German landscape when targeted analysed the German hospital market
perfect graphical representations

Second Notified Body TUV Sued

TUV Sued is second Notified Body after MDR

CE Mark is awarded by Notified Body
photo: IStock
CE Mark is awarded by Notified Body

16.06.2019 – TUV Sued Product Service has been recognised by the “Central Office of the Countries for Health Protection with regard to Pharmaceuticals and Medical Devices” (ZLG) as the second Notified Body for the new Medical Devices Regulations (MDR) after the British-Dutch BSI.


Hub for medical tourism in Dubai

Dubai hub for medical tourism and innovative health start-ups

16.06.2019 – DUBAI. The ruler of Dubai, Sheikh Mohammed bin Rashid al Maktoum, who is also Vice President and Prime Minister of the United Arab Emirates (UAE), has the vision to develop Dubai into a global hub for medical tourism. Therefore, medical tourists from all over the world should not only be treated by internationally recognized specialists, but Dubai should also become of great importance for innovative health start-ups with a focus on smart-health.


Medical Device Market in South-Africa

Reforms and lifestyle changes bring good growth opportunities for foreign medical device manufacturers in South-Africa

March 2019

Medical Technology:

According to a study conducted by Business Monitors International (BMI Research), the medical device market in South-Africa is expected to grow from $1.3 billion US to around $1.7 billion US by 2021.


US Commercial Consul Invitation

US Consul, Ken Walsh invites for Lunch

Invitation to the US Commercial Consul in Duesseldorf
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.


Israel excellent market opportunity

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. Weiterlesen