IVDR 2017/746 Online Training Course

Course Description

This 2-day, instructor-led, online course will provide a detailed overview of the European Regulation 2017/746 related to In Vitro Diagnostic Devices.

IVDR will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC). As a European regulation, it will be effective in all EU member states and EFTA states immediately without need to be transferred into the law of respective states, however national laws may be adapted to back up some requirements in more detail. Manufacturers of currently approved in vitro diagnostic medical devices will have a transition time of five years, up to May 26, 2022 to meet the requirements of the IVDR.

Products already certified by a Notified Body may be placed on the market for further 2 years under some conditions, e.g. the certificate issued under the IVDD is still valid and subject to surveillance by the Notified Body who had issued it and no significant changes to the product are made.

Manufacturers of in vitro diagnostic medical devices are well-advised to stay current on amendments to IVDR by training and retraining staff over the next few years. Under the IVDR, all currently approved in vitro diagnostic devices must be recertified in accordance with the new requirements. There are no grandfathering provisions, so it is time to help your organization understand this regulation.

NEWS - June 17, 2020: TÜV SÜD Designated as a Notified Body Under the IVDR

Course Benefits

This course is designed to make your transition into IVDR, the new regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market, less complex and less time-consuming.

Who Will Benefit?

This course is designed for medical device manufacturers who place on the market, make available and put into service in vitro diagnostic medical devices on the European market.

Learning Objectives

• Identify the changes introduced by the Regulation
• Appraise processes and structural impacts of the regulation on their organization
• Develop strategies to answer new requirements and prepare a smooth transition

Key Topics:

• Quality Management System (QMS) requirements
• Product classification and conformity assessment routes
• Content of Technical Documentation
• Clinical Performance Requirements
• Labeling requirements, including UDI and registration
• Post Market Surveillance program

Course Agenda

Day 1:

9:00 am –10:30 am:

• Intro to Regulation
• Scope and Definitions
• Management Responsibilities
• Quality Management System Requirements

10:45 am –12:15 am:

• Group exercises

12:15 am –1:00 pm: Lunch break

1:00 pm –3:00 pm:

• Rules of Classifications
• Conformity Assessment routes

3:00 pm –5:00 pm:

• Group workshop
• Summary of the day
• Discussion

Day 2:

9:00 am –10:45 am:

• Technical Documentation Requirements
• Clinical Performance

11:00 am –12:15 am:

• Group exercises

12:15 am –1:00 pm: Lunch break

1:00 pm –3:00 pm:

• Post Market Surveillance Program (including Post Market Performance follow-up, Periodic Safety Update Reports, …)

3:00 pm –5:00 pm:

• Group workshop
• Summary of the day
• Discussion
• Exam

Methodology

• Instructor-Led, Online, Virtual Classroom

Duration

• 2 Days