This webinar will focus on medical devices with ancillary medicinal substance and the conformity assessment process and key requirements. A variety of topics will be covered including:
- MDR Rule 14
- Impact of MDCG-2020-12
- Documentation Requirements for medicinal consultation
- Conformity Assessment process and timelines
- Competent Authority Considerations
- Pre-Submission Meetings
- Notification of intent to submit
- Available Options
- Impact of Brexit
Who should attend the webinar?
This webinar will offer notified body insights for all people involved in working towards an MDR application, whether you are a novice or have significant experience of working with a notified body.
Manufacturers who are currently developing or have within their portfolio devices that contain an ancillary medicinal substance (MDR Rule 14 Devices).