Introduction to the Medical Device Regulation (MDR).

This course gives an overview of the structure and revised scope of the MDR. Understand the role of the safety and performance requirements as the basis for CE marking and how to determine the appropriate conformity route.

The course addresses the reasons to create a more effective regulatory system and a route map will be provided to illustrate the steps that are required to achieve compliance.

• Individuals responsible for regulatory compliance working in an organization involved in any aspects of medical device manufacturing, designing or marketing and need to learn why we are moving from a Directive to a regulation
• Manufacturers that need to identify the important changes and their relevance
• Those who are in the process of building a transition plan for certification to the new regulation.

• The new structure and revised scope of the MDR
• New classification rules
• Role of the safety and performance requirements as the basis for CE marking
• How to determine the appropriate conformity route for your products
• Technical documentation changes and new requirements under the regulation
• The requirements for performance evaluation
• Necessary steps required for post-market surveillance and the reporting of adverse incidents under the vigilance system
• Hot topics under the new regulation including supply chain requirements, your commitment to device identification, defining the person(s) responsible for regulatory activities, new definitions and timeline to transition.

Basic knowledge of medical device use or manufacture.

• Training course materials
• Lunch and refreshments for public attendees only
• Certificate of attendance.

• Implementation of the Medical Device Regulation (MDR)
• Introduction to the InVitro Diagnostic MDR EU 2017/746
• Implementation of the In Vitro Diagnostic Device Regulation (IVDR)
• ISO 13485:2016 courses
• ISO 14971:2012 courses

One day.