November 20, 2023
Find out the importer’s requirements under the MDR/IVDR. Plus, what are the manufacturer’s obligations to/from the importer and how are direct sales handled?
October 24, 2023
Overview of Shelf Life, Expiration Dates, Device Lifetime/Useful Life and Service Life for medical devices and IVDs in Europe.
June 9, 2023
Page Last Updated: 20 December 2023 Definitions: Systems, Procedure Packs, Kits Systems and Procedure Packs MDR, Article 2(10): “‘procedure pack’ means a combination of products packaged […]
June 2, 2023
Clinical Evaluation Plans are a critical part of medical device clinical evaluation under the MDR. Find out how to get it right.
April 18, 2023
Comprehensive guide to EU MDR transition period extension per Regulation 2023/607. Included: timeline of key dates, FAQs, & Before vs After table of the changes.
February 7, 2023
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
Learn the difference between market surveillance & post-market surveillance. Plus how PMS Plans, Reports, PMCF/PMPF, Trend Reporting & Vigilance all intertwine.
August 4, 2022
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
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 ...