Overview

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
• Timelines
• 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.

• Regulatory Affairs professionals
• Manufacturers who are currently developing or have within their portfolio devices that contain an ancillary medicinal substance (MDR Rule 14 Devices).

What will participants gain?

Join this insightful webinar, to hear from Theresa Jeary, Medicinal Expert, BSI, as she explains more about the conformity assessment process for devices containing an ancillary medicinal substance. The webinar will also be helpful for those looking at strategic planning considerations and who would like to understand more about the timelines to facilitate MDD to MDR transition planning.