Product licensing / registration
Manufacturers, who wish to introduce their product into a certain target market, must meet the applicable regulatory, legal and normative requirements.
Within the European Union, medical devices, active implantable medical devices and in-vitro diagnostics must carry a CE mark before they can be marketed. In order to place the CE mark on a product, the manufacturer must prepare a „Declaration of conformity (DOC)”, in which they confirm that the requirements set out by the European directives have been met.
The following activities are provided by our consultation services:
- identification of registration requirements
- development of registration concepts
- preparation of registration documentation
- application for registration
- application for the notification of the medical technical aids in the register for medical technical aids reimbursement list („Hilfsmittelverzeichnis der Krankenkassen”=HMV) of the German health insurance funds
We will also guide you through the licensing/registration procedures in Non-European countries and will provide authentic support locally through our competent consultant network.