Seminar on Medical Technology: What news does MDR bring?
The Swedish Pharmaceutical Society invited us to a talk about the new EU Regulation for Medical Devices (MDR 2017/745). It was very welcome to me because the regulation is 175 pages of text that all European medical technology translators need to be familiar with. It was great to get some guidance on the biggest changes.
MRD increases the responsibility for importers, distributors and other persons who will be more responsible for product quality and safety. In addition, the requirements of the notified bodies are tightened. Authorized representatives and importers are registered along with the manufacturers of the European database Eudamed, and assigned a Eudamed Single Registration Number (SRN). Also, a new system for unique product identification (UDI, UDI database) is introduced, which will certainly be mentioned in translations.
Extra interesting for translators is that importers and distributors now have the right to translate medical device documentation about a product that has already been placed on the market, or additional information needed to market the product.