This course is intended for manufacturers of medical devices class I according to the Medical Device Regulation (MDR).

To place a medical device on the market within the EU, it must be CE-marked according to the Medical Device Regulation (MDR).

It is important to establish a regulatory strategy and plan for how to CE-mark the device. The first step is to qualify your device as a medical device and classify it according to the classification rules in MDR, both based on the intended purpose for the device.

In this course, we will go through the basis of the CE-marking process and requirements in MDR for manufacturers of class I devices. Class I is the lowest risk-class.

During the course, you will gain knowledge on the requirements for manufacturers to fulfill to be able to place a CE-marked device on the market. Looking closer at the most important parts of MDR, looking at the importance of a well-defined intended purpose, technical documentation, and quality management system.

Topics

• Why do you need to CE-mark your device?
• How to qualify and classify a medical device
• Quality management system for class I manufacturers
• Basics in technical documentation and General Safety and Performance Requirements (GSPR)
• The role as Person Responsible for Regulatory Compliance (PRRC)
• Post Market Surveillance and vigilance
• Interaction with competent authorities
• Important terms and definitions, guidelines and standards

Recommended prior knowledge
No previous knowledge of quality and regulatory work is required.

Course presentations
The course will be held in Swedish with material in English.

How to get deeper knowledge
To get additional and deeper knowledge of how to create and maintain your technical documentation, add the course Technical Documentation for medical devices (ext link to Swedish Medtech)

Course leader
Anneli Wiedenkeller, Senior Quality and Regulatory Consultant