IVDR in a nutshell – the roadmap to CE-certification

What is required from your technical documentation and your Quality Management System, to become IVDR compliant and achieve CE-certificate for your Class B, C or D in-vitro diagnostic devices? When is an NB required and what do they require? How do I manage my Class A devices?

This course provides you with a full understanding of IVDR specific requirements on your Technical Documentation as well as your Quality Management System, and how to apply a risk-based approach both when preparing Technical Documentation and when designing the Quality Management System.

Course description

• Conformity assessment routes – do I chose this myself, if so how?
• How do I define harm, and perform risk assessment, for my in-vitro diagnostic device?
• How do I write a plan for postmarket surveillance and postmarket performance follow-up that will support continuous benefit-risk assessment?
• What does it take to fulfil requirements on performance evaluation and clinical evidence?
• What about legacy devices?
• How do I design a quality management system proportionate to the risk of our devices?

After this one day training you will be better equipped to tackle the questions above. We’ll walk you through the key IVDR requirements on your quality management system and provide you with tools to perform a gap analysis of your technical documentation and your quality system. The relationship between ISO13485:2016 and IVDR will be discussed and the IVDR requirements that are not covered by the standard pointed out.

The requirements posed on specified roles such as authorized representative, importer, distributor and “legal” manufacturer will be discussed as well as how to define and document relationships to other parties, i.e. AR, subcontractors, suppliers and between an OBL manufacturer and the OEM.

Finally, we will cover how the interrelation between clinical evidence evaluation, risk management and post-market surveillance can be demonstrated in your quality system.

Course outline

In this course you will learn how to:

• Define the “Intended use” and the impact it has on all activities; from risk management to performance evaluation and even the design of the quality management system
• Identify information which is sufficient and relevant to write the performance evaluation report
• Identify and implement the IVDR requirements on your quality management system
• Make use of ISO13485:2016 to manage regulatory requirements
• Assess and/or audit your internal quality management system against IVDR

Learning objectives

Completion of this course will give you the knowledge needed to assess and update your current technical documentation and quality management system for IVDR compliance.

Who should attend

The course is suitable for persons involved in, or responsible for the operation or audit of a Quality Management System for in-vitro diagnostic medical devices who need to know the changes that comes with the implementation of the IVDR.

Prerequisites

• You should have knowledge of medical device quality systems from working with IVDD and/or ISO13485.
• You should have at least 2 years of experience from the medical device industry.

#5138