CE Marking of Medical Devices (MDR/IVDR) - Deep Dive - Day 2

As a manufacturer, importer, or distributor of medical devices on the EU market, you operate in one of the world's most regulated landscapes. CE marking is not just a label – it is proof that your product meets strict requirements for safety, performance, documentation, and quality management. This training provides a clear and practical walkthrough of what it takes to CE mark your product and bring it to market.

This is part 2 (day 2) of the course CE Marking of Medical Devices (MDR/IVDR) the big picutere - day 1. You must have attended day 1 to be able to attend day 2.

The requirements have tightened significantly under MDR and IVDR: UDI labelling, cybersecurity, enhanced clinical evaluation, and more extensive technical documentation are just a few examples. We cut through the complexity – and help you see the full picture.

The fundamental purpose of the regulations is to protect patients and users. But the consequences of non-compliance are also very real: market bans, product recalls, and liability claims. This course focuses on the path to CE marking. We explain, discuss, and practice key concepts – and walk through how technical documentation should be structured and what role regulatory authorities and Notified Bodies play.

Programme Overview

Day 2 – Deep Dive

• Technical documentation: structure, content, and common deficiencies
• Quality management systems under MDR/IVDR and ISO 13485
• Labelling and instructions for use
• Introduction to key process standards:
• ISO 14971 (risk management)
• IEC 62366-1 (usability)
• IEC 62304 (software)
• Cybersecurity: IEC 81001-5-1 and MDCG 2019-16
• Artificial intelligence and medical devices, including the AI Act
• Post-Market Surveillance and Vigilance
• Notified Bodies and the certification process (with a guest representative from Intertek)

The course combines lectures with multiple hands-on exercises and practical activities, including exercises on intended purpose, usability, and labelling.

Course Objectives

The aim is to give you a solid and practically applicable understanding of how CE marking works for medical devices – from regulatory framework to real-world implementation.

Who Is This Course For?

The course suits anyone seeking a comprehensive overview of the EU requirements placed on medical devices and the companies that bring them to market. It is particularly relevant for those with responsibilities in development, regulatory affairs, quality, production, or marketing, as well as members of management teams and professionals from healthcare procurement and clinical functions.

Prerequisites

Some experience in the medical device field is an advantage, but not a requirement. You must attend part 1 (day 1) CE Marking of Medical Devices (MDR/IVDR) the big picutere - day 1 to be able to attend day 2.

Course language

 English

Upcoming classes

Please note:

Intertek operates under strict standards of independence, impartiality, and integrity. Read more about how we work here: https://www.intertek.com/about/compliance-governance/