Position papers

Evaluation questionnaire from May 2016

Analysis of expenses and changes from the point of view of medical technology companies in the MedicalMountains cluster.

After a long struggle, the final draft for the Medical Device Regulation (MDR) of the European Union is finalized and the adoption is foreseeable. However, a number of tightenings have already taken effect in the industry.

What additional costs are incurred, or have already arisen, how severe is the impairment in the course of the business, how much is the future viability affected? MedicalMountains has put these questions together in a survey to substantiate arguments with hand-held, robust data from the companies themselves. The survey is intended to reflect the current mood situation and changes already made in the industry.

The survey was sent to around 500 companies in the medical technology sector. The companies are mainly located in the region of Tuttlingen / Schwarzwald-Baar-Heuberg, but also in the neighboring regions as well as in the whole of Baden-Württemberg. A total of 121 companies participated in the survey. This response rate can give a good mood picture.

Here you can download the results of the survey (in German):
Evaluation Questionnaire May 2016

For over two and a half years, the Chamber of Industry and Commerce Schwarzwald-Baar-Heuberg and MedicalMountains have been working together with honorary entrepreneurs in the industry to carry out improvements to the planned European Medical Devices Ordinance (MDO).

Our input has already shown to be successful. Many of our requests, which are also supported by you, are reflected in Parliament’s current draft regulation. For example, the renowned Freiburg-based law firm Graf von Westphalen has concluded in an investigation that more than half of our suggestions for improvement have found their way into the draft law (current state of implementation).

We are delighted to be able to thank all those who have worked for the German medical technology industry.

Unfortunately, the draft of the Council of Ministers is not so gratifying. Together with an expert panel from the business sector, we have created a position paper with the most important change points (Position paper in September 2015).

Additions to the position paper from 07.03.2013
Medical device manufacturers rely on responsible action rather than over-the-counter legislation from Brussels.

After the numerous discussions that we conducted on the basis of our position paper of March 2013, we developed a supplement to the position paper together with the medical technology industry.

We focus in detail on two essential aspects of the new regulation:

1. Inflation of well-established medical products into higher risk classes
2. The demand for more and more clinical trials

The medical technology manufacturers follow a long tradition that distinguishes the medium-sized company with regard to the quality of its products and its commercial reputation. With their own names, these producers guarantee the highest quality and are fully aware of their responsibility for patients, society and their companies. The primary goal of the medical technology companies is a reliable and comprehensive patient care as well as the best possible patient protection.

With the present document, we are once again calling upon all parties involved in the discussion and decision-making process to keep an eye on the definition of the new European regulations, and to involve not only the manufacturers of medical technology, but all the stakeholders in the health system in the safety assessment of our patients.