Date: 8th of March 2022
Time: 17:00h -19:00h CET
Location: Virtual
Language: English
Costs: € 395,-
Package deal (12 sessions): € 3750.- *
* Team Members with Different Roles & Responsibilities? No problem!
We offer flexible options for your company, team, or individual experts. You can send different delegates from your company to the sessions and still qualify for the package.
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).
Learning Objectives:
- Understand the MDR requirements for clinical evaluation
- Recognize and define clinical claims and clinical risks
- Be able to scope a clinical evaluation and draft a Clinical Evaluation Plan
Trainer: