On May 26, 2021, the transition period from the previous European Medical Device Directive MDD 93/43/EEC to the new European Medical Device Regulation EU MDR 2017/745 ended. Importers and distributors, who played only a minor role in the MDD or were not mentioned so far, are now covered and entrusted with responsibilities.
At the same time, the new nationally applicable Medical Device Law Implementation Act (Medizinprodukterecht-Durchführungsgesetz, MPDG) also came into force, which now explicitly mentions distributors and importers. The previous Medical Devices Act (Medizinproduktgesetz, MPG) was thus replaced.
But what exactly do the changed requirements of the new EU MDR entail, and why are distributors and importers much more than a mere pass-through station for medical devices? In a new white paper, gempex has summarized all the main changes in a clear and understandable way. The white paper differentiates between testing and monitoring obligations, handling, communication and documentation obligations arising from the EU MDR. Practical aspects are highlighted and cases are presented in which importers and distributors must implement a quality management system according to the EU MDR.
Please request the white paper The Role of Distributors and Importers in the Context of EU MDR and MPDG by e-mail to: info@gempex.com
For all questions regarding medical devices, the Medical Devices Compliance Team is available at any time: contact@gempex.com