April 21, 2024

Clinical Evaluation Reports: General Structure and What to Include

Clinical evaluations are mandatory for all medical devices marketed in the EU. Find out the specific requirements under the MDR, including how to structure it and what to include.
November 20, 2023

EU Guide: Importer Requirements under the MDR/IVDR

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

EU Guide: Shelf Life, Expiration Date, Expected Lifetime/Useful Life, Service Life, Life Cycle

Overview of Shelf Life, Expiration Dates, Device Lifetime/Useful Life and Service Life for medical devices and IVDs in Europe.
June 9, 2023

EU, Swiss, UK Guide: Systems/Procedure Packs and Kits

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: How to get it right

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

MDR Transition Extension Guide

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

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.
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.