Use our smart tools to efficiently enter the German speaking (D-A-CH) market.

Market Access 
10.06.2020

Regular reimbursement for medical apps in Germany

With the Digital Care Act (DVG), structures were created to establish regular reimbursement for digital health applications (DiGA) in Germany. Evidence for the positive care effect (pVE) of the DiGA is your ticket to the SHI market and thus to secure reimbursement. With the question which requirements of the authorities have to be fulfilled, you will also come across the topic of evaluation of your app. We have summarized the most important facts for you. 

More information on evaluation of DiGA in the German market (in German)

Market Access 
30.08.2019

New book “Market Access for Medical Devices”

Market access for medical devices is becoming increasingly complex. On the one hand, products are more and more technically demanding, on the other hand, national and international regulations for approval are constantly changing. Successful market access requires not only approval but also reimbursement by the statutory health insurances. This new book therefore aims to provide practical advice on approval and reimbursement for your market access strategies.

Order your book from Amazon in German language. Please contact us if you are interested in English language information on market access for medical devices.

Market Access 
07.04.2018

Evidence Generation –  a focus of the Medical Device Regulation (MDR). We show you how to get a good starting position in 7 steps.

The EU MDR was designed to ensure safety and a rapid patients' access to innovative medical devices. It entered into force on May 25, 2017 and includes a three-year transition period. During this transitional period, either old (policy 93/42/EEC; and 90/385/EEC) or already new medical device legislation can be applied. From May 26, 2020, the new EU Medical Devices Regulation will then be compulsory. Therefore, it is very advisable to gain experience with MDR just now in the transitional phase. To do so, however, the requirements on the part of the certification bodies, the so-called Notified Bodies, must also be fulfilled.

Read the full article here (in German) or contact us for the article in English and for more information on the new EU MDR regulation and its evidence requirements.

Market Access 
09.02.2017

Section 137e of the German Social Security Code Volume V for medical devices – many consultations, few trials!

The introduction of Section 137e of the German Social Security Code Volume V in 2012 provided the Federal Joint Committee (G-BA) with an instrument to initiate clinical trials for medical devices with high relevance as part of ongoing method evaluation studies. The Federal Joint Committee reports that so far there has been growing interest in the consultations on the trial regulation held by the Federal Joint Committee, but only few trial procedures to be examined. 2017 (5 years after the introduction of the regulation!) was the first year the trial regulation was applied for the MR-guided high-intensity focused ultrasound treatment for uterine fibroids (MRgFUS-TUF/MR-HIFU).

Read the full article here (in German) or contact us for the article in English and for more information on the early benefit assessment of high risk products.