Training

Clinical Training | Clinical Evaluation Under the MDR

October 14, 2021

DateOctober 14th &15th, 2021 ( 2 sessions, 1 session per day)

Time: 9-11am PT | 12-2pm ET 

Location: Virtual

Early Bird Price: $199 (Ends 10/10/2021)

Regular Pricing: $399

Trainer: Jasmin Hunter

Introduction:

Manufacturers struggle to address requirements for clinical evaluation for all classes of devices, with many erroneously assuming class I devices will not need clinical data. Clinical evaluation is required for all medical devices regardless of risk classification or clinical data requirements. While the ideology of evaluating clinical evidence to demonstrate compliance with relevant General Safety and Performance Requirements remains unchanged, the medical device regulation (MDR) 2017/745 along with the recently published MDCG 2020-5 Guidance on Clinical Evaluation - Equivalence and MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices includes stringent requirements for acceptable clinical data, demonstrating equivalence to a marketed device, and the ability to establish conformity for devices in which clinical data is not deemed necessary (Article 61 section 10). 

These virtual training sessions will walk you through how to establish endpoints for clinical claims that will make identifying and assessing relevant literature and other clinical data sources more straightforward. Practical examples of devices that meet the requirements of Well-Established Technology or MDR Article 61 (10) will be provided as will common pitfalls for establishing equivalence. Manufacturers struggle to address requirements for clinical evaluation for all classes of devices, with many erroneously assuming class I devices will not need clinical data. Clinical evaluation is required for all medical devices regardless of risk classification or clinical data requirements. While the ideology of evaluating clinical evidence to demonstrate compliance with relevant General Safety and Performance Requirements remains unchanged, the medical device regulation (MDR) 2017/745 along with the recently published MDCG 2020-5 Guidance on Clinical Evaluation - Equivalence and MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices includes stringent requirements for acceptable clinical data, demonstrating equivalence to a marketed device, and the ability to establish conformity for devices in which clinical data is not deemed necessary (Article 61 section 10). 


Jasmin Hunter
Post date: June 01, 2021
Tags
How can we help you? Contact us