Learn more about how to address EU MDR challenges from medical device experts Mark Agostino and Alison Sathe in this clip from the Oct. 28, 2021 Redica Systems webinar.
Looking for more EU MDR information? Check out our EU MDR Playlist: [ Ссылка ]
The new European Union Medical Device Regulation (EU MDR) (EU) No. 2017/745) and In Vitro Diagnostic Regulation (IVDR) present the first major changes to the EU medical device regulatory environment in over 20 years. The two regulations replace three existing Medical Device Directives (MDD).
If you are a manufacturer, authorized representative, importer, or distributor of medical devices in the EU, regulatory affairs or quality management professional involved with medical devices, you need to know how to comply.
Who does the EU MDR affect? The EU MDR includes all items sold within the European Union. However, all manufacturers that wish to sell their products in the European Union need to ensure that they satisfy the EU MDR requirements or the sale of their products will be prohibited; this includes other countries such as the United States selling products to Europe.
