Datum: 08. September 2021

Zeit: 10:00 -11:00 Uhr (CET) and 17:00 - 18:00 Uhr (CET)

Sprache: Englisch

What’s this webinar about?

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, Technical Specialist and Scheme Manager, 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.

Theresa Jeary holds a master’s degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland and is eligible to be a Pharmaceutical Qualified Person. 

Theresa has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early-stage development, process transfer, validation and regulatory departments. 

In addition to her product development and global regulatory expertise, Theresa has over 12 years Notified Body experience, first at BSI as a technical expert for devices with ancillary medicinal substance and borderline classifications, moving then to LRQA where she held the role of Head of Notified Body for several years.  Theresa re-joined BSI in August 2020 working as a technical specialist in the Medicinal and Biologics Team.