January 31, 2023

MDR/IVDR Market Surveillance & Post-market Surveillance

Learn the difference between market surveillance & post-market surveillance. Plus how PMS Plans, Reports, PMCF/PMPF, Trend Reporting & Vigilance all intertwine.
August 4, 2022

Declaration of Conformity Requirements: EU, the UK and Switzerland

Find out how to create medical device Declarations of Conformity for Europe, the UK and Switzerland. Plus, Procedure Packs and Custom-made device statements.
June 22, 2022

Steps and timing to transfer your EU Authorized Representative (EC Rep)

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

‘Placing on the Market’: Definition and Cutoff Dates for EU, UK & Switzerland

Why does 'placing on the market' matter? EU definition of 'placing on the market' UK definition of 'placing on the ...
March 14, 2022

EUDAMED Actor Registration FAQs

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

Labeling Requirements for the EU, UK and Switzerland In-Country Representative

Manufacturers selling in the EU, UK and Switzerland need to consider the different labeling requirements for listing their in-country representatives ...
January 31, 2022

How to Find GMDN Codes for Free

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 15, 2022

CE Marking to the IVDD versus the IVDR

Is it worthwhile to CE mark to the IVDD, so close to the IVDR's date of application? The IVDR date ...
January 5, 2022

What are Legacy Devices?

In short, legacy devices are: MDD 93/42/EEC Class I self-certified devices, which have been up-classed under the MDR and therefore ...