February 8, 2023

Transfer your Swiss Authorized Representative (CH-REP): Steps and Timing

Find out the steps and timing to transfer your Swiss Authorized Representative (CH-REP) for medical devices and IVDs.
February 7, 2023

List of EU MDR/IVDR Harmonized Standards & Common Specifications

Click here to access a list of the European MDR/IVDR Harmonised Standards & Common Specifications. Casus has centralized these into one page for easy access.
January 31, 2023

EU MDR/IVDR Guide: 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.
October 18, 2022

UKCA Marking: Fact Sheet for Medical Devices & IVDs

Read our Fact Sheet to find out: UKCA Marking deadlines; UKCA versus CE Marking technical file and labeling differences; where to download the symbol; and more.
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

Transfer your EU Authorized Representative (EC Rep): Steps and Timing

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 ...
March 1, 2022

Northern Ireland Medical Device Requirements

Northern Ireland has one foot in the UK door and one foot in the EU door. Find out what is really needed to sell your medical devices in Northern Ireland.