Learning Marketplace

Medical Device Directive (MDD) to Medical Device Regulation (MDR)

This course introduces you to the key changes from the European Medical Device Directive (MDD) to the new European Medical Device Regulation (MDR). All medical devices and identified devices without a medical purpose will need to undergo a conformity assessment procedure based on the new MDR requirements, in order to place devices on the European Union market. The course will give a general guideline of how to approach application of the new MDR, and will highlight the differences to the MDD that will affect all manufacturers.

Benefits to Your Business

·         Understand the key changes in the transition from the Medical Devices Directive to the new Medical Devices Regulation

·         Communicate the impact to your organization of the key changes introduced by the MDR, and the transition arrangements defined within the MDR

·         Identify the next steps for your organization to meet the MDR requirement

Learning Objectives

·         On completion of this training, participants will be able to:

·         Explain the changes in the structure and administration of the regulation

·         Recognize new economic operators affected by the regulation

·         Identify key changes to the requirements concerning the following steps for conformity assessment:

·         Check device is within the scope of the MDR

·         Determine risk class of device

·         Select conformity assessment procedure

·         Identify applicable safety and performance requirements

·         Assemble technical documentation

·         Apply conformity assessment procedure    

·         Assign unique device identification (UDI)

·         Complete Declaration of Conformity (DoC)

·         Affix CE mark

·         Post-Market Surveillance and Updates       

·         Explain the main impacts on the QMS relating to the above steps, including:

·         Frequency, extent and conduct of audits

·         Electronic data management and public access to data

·         Clinical investigations, clinical evaluation and post-market surveillance

·         Roles of commercial partners

·         Communicate the transition arrangements as stipulated within the regulation

Intended Audience

Manufacturers of medical devices, especially: Regulatory Affairs, Design and Development, Clinical Affairs Specialists, Quality Management, and Quality Assurance personnel.

Prerequisites

Good understanding of the existing Medical Devices Directive (93/42/EEC)

Upcoming Course Dates

The venues for scheduled courses are tentative until receipt of course confirmation from BSI.

Start/End Date and Time Location Fee Enroll
  • Nov 07, 2018 9:00 AM - 5:30 PM
Dulles, VAUSD $1400.00Enroll