The ZLG plays a central role in the German market for medical devices. It coordinates the surveillance of medical devices in the market and acts as a point of contact for the competent authorities of other states and the EU Commission. In addition, the ZLG is responsible for the designation and monitoring of conformity assessment bodies within the framework of agreements between the European Community and third countries. Another important area of activity of the ZLG is the exchange of experience at EU level and the provision of advice on matters relating to EU agreements with third countries.
The ZLG was founded in 1993. Its origins go back to the introduction of the Medical Devices Act (MPG), which created the legal basis for the regulation of medical devices in Germany. Further information on the ZLG can be found on its homepage.
Despite legal reorientation, the ZLG retains its central role in approvals and certifications. We would be happy to explain to you in the context of your individual case how exactly these processes are designed. NEMIUS has excellent contacts with ministries, authorities and notified bodies, thus ensuring that your matters are dealt with in a targeted and timely manner. Well prepared by our professional expertise, you will save valuable time. Contact us today.
