Medical Device Regulation (MDR)

Medical Device Regulation (MDR) – new regulations for the medical sector

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.


Here are the five most important points to note:
  • Who will be affected?
    Manufacturers of medical devices that sell their products within the EU
  • What needs to be adapted?
    Instruction manuals, labelling, packaging, technical documents
  • What needs to be taken into account?
    The guidelines of the Medical Device Regulation (MDR) and the EU Regulation on In-Vitro Diagnostic Medical Medices (IVDR) must be observed
  • When must the materials be adapted by?
    26 May 2021
  • What will the consequences be if the deadline is not adhered to?
    There is a risk of criminal proceedings and thus the danger that the medical devices may no longer be sold in EU countries


The following must be taken into account

The MDR contains regulations for the following areas, among others:

  • Information on products
  • Information on the use of instruction and operating manuals
  • Information on identification and labelling
  • Information on controlled clinical studies and documentation of clinical data as well as reviews of compliance with the MDR regulations are carried out by “notified bodies”

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.


How can we support you?

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.