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
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
Manufacturers of medical devices, especially: Regulatory Affairs, Design and Development, Clinical Affairs Specialists, Quality Management, and Quality Assurance personnel.
Good understanding of the existing Medical Devices Directive (93/42/EEC).
All Upcoming Course Dates
|Date and Time||Location||Fees||Enroll|
|Sep 19, 2022 10:00 AM - 6:30 PM ET||Live Online - Full Day||CAD $1400.00||Enroll|
The venues for scheduled courses are tentative until receipt of a course confirmation from BSI.