Regulatory Affairs Medical Technology
Legal requirements for the quality and safety of medical devices play a decisive role in medical technology for access to the German and European market. The application of the EU Medical Device Regulation (MDR) and other legal regulations, for example for radiation protection in medicine, are of enormous importance for medical device manufacturers, as are growing cyber security requirements due to the increasing digitalisation of the healthcare system.
The ZVEI accompanies these and other topics through its work in specific focus groups and represents the interests of its members vis-à-vis national and European authorities and institutions. As a member of the European industry association COCIR, ZVEI also participates in the corresponding discussions at European level. The information in this topic area is available to all ZVEI members.
Contact: Hans-Peter Bursig
Digitalisation and medical technology
The digitalisation of healthcare and electromedical technology go hand in hand. Digitisation in the medical technology sector has many facets. For the research and development of medical devices, data transmission from or to the medical device and the associated uniform generation of data as well as the evaluation and use of this data play a major role. However, digital medical devices can also be used to digitalise all processes related to the treatment of a patient. For example, digital processes can optimise the management of all medical devices in a hospital. In the end, however, what counts is to simplify the processes for the medical staff and to put the patient in the centre of attention. Medical technology is thus a driver of digitalisation. In the Electromedical Technology Association, the ZVEI is developing solutions to fully exploit the potential of "digital medical technology" for modern healthcare.
Contact: Pia Grass
Medical technology and innovation
Innovations in medical technology benefit patients when the access routes in Europe and the remuneration system in Germany are practicable and financially manageable for manufacturers. In addition to the barriers to market entry, the ZVEI's Electromedical Technology Association is also concerned with the life cycle and the service processes that have to be coordinated with customers in the process, and supports its members with various instruments for export promotion. Product and market-related information as well as active advocacy for digital forms of care complete the association's work.
Contact: Andreas Bätzel
