CE-marking – Risk classification of IVDs & Technical Documentation

This is Part 2 of 3 in our IVDR training series. (Click the titles below for information)

Special Bundle price for all 3 parts: 1250 Euro – Order the bundle here →
Note. All parts are stand-alone, and you can attend one or more of them.

The new EU regulation on In Vitro Diagnostic Regulation (IVDR 2017/746) is reshaping the entire IVD industry with stricter requirements, risk-based classification and enhanced post-market obligations. Demonstrating compliance for CE-marking of IVD devices has become more rigorous and there is no room for shortcuts.

If you are in the IVD industry, this training series is your gateway to understanding the IVDR and the CE-marking process.

Take the opportunity to gain clarity and confidence, IVDR isn’t optional— it’s mission-critical.

Course description

This course is the second of three modules in our new IVDR training series “Mastering IVDR Compliance: From Fundamentals to Post-Market Excellence”. The course is taking a deeper dive into IVDR exploring the risk classification and its implications, the general safety and performance requirements in Annex I and the creation of Technical Documentation.

The risk classification and the Technical Documentation are essential parts of IVDR and fundamentals for CE-marking. This course explains the shift to the new rule-based risk classification of IVDs and its practical implications. You will gain a clear understanding of the importance of the intended purpose and how to apply the classification rules to determine appropriate risk class. Following the risk classification, the course focuses on exploring the general safety and performance requirements – the backbone of IVDR, and how to create the Technical Documentation to demonstrate compliance with the requirements. Details on the structure and content of the Technical Documentation will be further explained and how to maintain the documentation during the entire lifetime of the product.

Whether you need to learn the details or seek a solid refresher, you’ll gain valuable knowledge to understand the details of the risk classification and the Technical Documentation.

Learning Outcomes/Benefits

Understand the details of the new rule-based risk classification and how to apply the rules on different types of IVDs
Gain skills in risk classification and determine risk class of your products
Identify applicable General Safety and Performance Requirements and to how demonstrate compliance
Design of labels and instructions for use
Know the content and structure to create the Technical Documentation

Course Content

Crafting a well-defined Intended purpose
The new rule-based risk classification and its implications
How to apply the classification rules determine the risk classification
General Safety and Performance Requirements and how to demonstrate compliance
Product information (IFU, labelling)
Tell the story – Structure and content of Technical Documentation
Creation and maintenance of Technical Documentation

Target Audience

This course is ideal for professionals within the IVD industry and IVD related research such as:

Regulatory Affairs managers/specialists
Quality Assurance managers/ specialists
Technical managers
Development managers/engineers

Prerequisites

Course Module 1: “Introduction to IVDR – Fundamentals of IVDR and CE-marking of IVDs” is strongly recommended since this course is the second part of the IVDR training series “Mastering IVDR Compliance: From Fundamentals to Post-Market Excellence”

and/or,

Knowledge of IVDR fundamentals and development of IVDs gathered through other IVDR training and/or experience.

Examples of such experience are:

Experience from IVDR, IVDD
Experience from development of IVD´s , medical device or related research products
Experience of e.g. methods, tests, software, instruments for IVD or related research.

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