June 22, 2022
Find out the steps and timing to transfer your EU Authorized Representative for medical devices and IVDs. Includes the process under the MDD/AIMDD/IVDD and MDR/IVDR ...
May 17, 2022
Why does 'placing on the market' matter? EU definition of 'placing on the market' UK definition of 'placing on the ...
March 14, 2022
Find out the difference between an Economic Operator and Actor, who must register as a EUDAMED Actor and why you should start your registration now ...
February 21, 2022
Manufacturers selling in the EU, UK and Switzerland need to consider the different labeling requirements for listing their in-country representatives ...
January 31, 2022
Need a GMDN code? Find here the three best ways to find GMDN codes for free. Plus, how to confirm that you selected the correct code & other GMDN FAQs.
January 5, 2022
In short, legacy devices are: MDD 93/42/EEC Class I self-certified devices, which have been up-classed under the MDR and therefore ...
January 3, 2022
While Basic UDI-DI was created to help streamline device identification, it continues to be a confusing concept to many.
January 3, 2022
Do you need a European Free Sale Certificate for export, but not sure how to get one? Find out here who is allowed to request one, the cost and time.
October 10, 2021
EUDAMED Module: UDI / Device Registration Once your Single Registration Number has been issued, you are ready to move foward ...