On 26 May 2021, the new Medical Device Regulation (MDR) will enter into force. Under this Regulation, manufacturers selling medical devices within the EU will be subject to additional requirements in order to guarantee the safety of certain medical aids, implantable medical devices, instruments, etc. To date, this sub-area within the field of medical care has been somewhat less strictly regulated by the German Act on Medical Devices (MPG) than (for example) the regulations governing the handling of drugs by the pharmaceutical industry.
The MDR contains regulations for the following areas, among others:
For manufacturers, dealers and importers of medical devices on the European markets, this will mean that, within just a few months, all their devices will need to have been adjusted to comply with the regulations in this new policy in order to be able to continue to sell their devices in the EU. One crucial aspect of this is providing the information in the necessary languages.
As an ISO 17100 and ISO 9001 certified translation agency with extensive knowledge of the Medical Device Regulation (MDR) and the Regulation on In-Vitro Diagnostic Medical Devices (IVDR), tolingo is able to offer you professional support by providing clear and compliant translation of all materials for your medical devices in all official EU languages.