Registration of Medical Devices: How, Where, and by Whom?
Before medical devices can be placed on the market in the European Union, they must be registered. While EUDAMED (European Database on Medical Devices) is not yet fully functional, transitional regulations apply, specific to each country. In Germany, these regulations...
Additional Requirements for Importers and Distributor by Authorities
It is no longer new that Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) impose certain requirements on importers and distributors of medical devices. These requirements are described in detail in: Article 13: General obligations of importers...
Important Change Regarding Reporting Incidents in the United Kingdom (UK)
Starting from August 31, 2023, reports of adverse events related to medical devices that have occurred in the United Kingdom (UK) can only be submitted through the national MORE-Portal (Manufacturer Online Reporting) of the Medicines & Healthcare products...
Actor registration module
As of December 01, 2020 the European Commission will make the Actor registration module available which will be the first of six EUDAMED modules. Read more on Youregulate…