This CE marking training will discuss the recent changes to MDD (Medical Device Directive), how to identify non compliance areas, contents of the technical file and essential requirements document and how to select notified bodies for MD compliance.
Why You Should Attend:
Medical devices cannot be shipped to Europe unless they are in full compliance with the Medical Device Directive. The compliance burden is very different depending on the classification of the device.
This session will cover the Technical File and Essential Requirements document, in which design documentation must be maintained; unless you are intimately familiar with the requirements in advance, this could be a serious compliance issue. Also contained will be the recent changes to the MDD, noncompliance with which opens the possibility of cessation of certification. Also, unlike domestic (US) regulations, the MDD requires clinical data – methods for gathering this data will be reviewed. Notified body selection is a critical aspect of MD compliance – this webinar will share some tips and provide experience in this area.
- Device classification distinctions, and what that means to you in terms of compliance burden.
- Technical File contents and organization.
- Review and selection of your notified body.
- How to show compliance with the Essential Requirements.
- Changes to MDD and their implications.
- What is expected for clinical data.
This webinar will provide valuable assistance to all device manufacturers who wish to sell product in the European Community. The employees who will benefit include:
- Top management
- Regulatory management
- Quality Management
- Sales and Marketing Management
- Quality Engineers
- Other personnel involved in development and implementation of the QMS