Introduction to IVDR – Fundamentals of IVDR and CE-marking of IVDs

This is Part 1 of 3 in our IVDR training series “Mastering IVDR Compliance: From Fundamentals to Post-Market Excellence”.
(Click the titles below for information)

1. Introduction to IVDR – Fundamentals of IVDR and CE-marking of IVDs
2. CE-marking – Risk classification of IVDs & Technical Documentation
3. IVDR Performance Evaluation, Risk Management, incl Post-Market Surveillance and PMPF

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 first of three modules in our new IVDR training series “Mastering IVDR Compliance: From Fundamentals to Post-Market Excellence”.

This first course provides a comprehensive introduction to IVDR giving you an overall understanding of the fundamentals, requirements, and practical implications for CE-marking of IVDs.

You will learn the scope, structure, and key principles of IVDR to understand its impact on new and existing IVD´s. Through interactive lecture sessions, real-world examples, and expert guidance, you will gain knowledge and practical insights into the implementation of IVDR and requirements for the CE-marking.

Whether you’re new to IVDR or seeking a solid refresher, you’ll gain valuable knowledge and insights to navigate the regulation in your daily work.

Learning Outcomes/Benefits

• Increase your understanding of IVDR and principles for CE-marking of IVDs
• Gain skills in qualification IVD´s to understand the difference from accessories, RUO, Lab equipment and test methods
• Increase your understanding of the new risk classification and how to apply the classification rules
• Interpret and apply the General Safety and Performance Requirements (Annex I)
• Describe the principles of a quality management system and how ISO 13485 supports in compliance with IVDR
• Describe the principles of conformity assessment and get some best practice

Course Content

• Key elements of IVDR and main changes from IVDD
• CE-marking road map
• IVDs, accessories, methods, laboratory equipment or RUO – what is what?
• New approach for risk classification of IVD´s
• General Safety and Performance Requirements – The backbone of IVDR
• Quality management and alignment with ISO 13485
• Overview of Technical Documentation
• Conformity assessment and Notified Body scrutiny

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
• Clinical/Medical Affairs managers
• Development managers/engineers
• Production managers/staff

Prerequisites

No prior expert knowledge of the IVDR is required, but a basic understanding of development or production of IVD´s, medical devices or other products in a regulatory controlled industry will help participants get the most out of the course.

Examples of such experience are,

• Basic understanding of IVDR, IVDD, MDR or MDD
• Basic understanding of quality management e.g. ISO 13485, GMP, GLP
• Experience from IVD, medical device or pharma industry e.g development or production
• Experience of e.g. methods, tests, software, instruments for IVD or related research
• Experience from Clinical/Medical affairs for IVD´s or medical devices

Duration

Half day (3,5 hours)

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