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)

Course Materials

Soft Copy: You will receive an email prior to the course with instructions on how to access the online Student Handbook, which can be viewed, downloaded or printed.

NOTE: Copies of the standards are not included in the class fee.

BSI will make reasonable efforts to have loaner copies available for use during the class, but students are encouraged to have their own copy. Soft copies of the digital loaner standard cannot be printed or downloaded.

Course Logistics

If your class is Live Online:

• Students need to connect to the class from any internet accessible location.
• Webcam and Microphone are REQUIRED.
• ALL course times shown are US EASTERN TIME.

If your class is In-person :

• You are encouraged to bring a laptop with you to class.
• Please bring a picture ID such as a driver's license, passport, or work badge to class for verification purposes.

*Session lengths could vary depending on amount of class discussion.