MDCG

Events Search and Views Navigation

Event Views Navigation

Today

Latest Past Events

New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference

Webinar

New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference The In Vitro Diagnostics Regulation (IVDR) took effect in May 2022 and has introduced substantial changes in the regulatory framework for in vitro diagnostic medical devices (IVDs) in Europe. IVD manufacturers are expected to meet more rigorous standards for clinical evidence, with […]

Free

Critical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies

Webinar

Critical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies In September 2022, European Commissioners published updates to the Manual on Borderline and Classification for Medical Devices, which provides clarifications for classifying devices as medical or in vitro diagnostic devices under the MDR and IVDR. This guidance describes how to […]

Free
Criterion Edge is a distinguished global provider in the MedTech industry, dedicated to advancing compliance and enhancing market success for Medical Device, Pharma, and IVD companies through expert regulatory, scientific, and clinical writing services.
Twitter Youtube Linkedin

SERVICES

RESOURCES

ABOUT

Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.

Read more about our privacy policy here.