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How to CE mark devices with non-medical purpose from MDR – Annex XVI?
Webinar Pre-Requirements: (Acquired knowledge of MDR TD Basics)
- What kind of devices fall under annex XVI?
- Common specification clarification
- MDCG guidances clarification
Overview of the webinar
Under the new European MD Regulation there is a list of Devices with non-medical purpose that are now subject to the Regulation. That list is described in Annex XVI and is mainly composed of devices used with an aesthetic purpose. Recently the European Commission published Common Specification for those devices and the MDCG group has published two new guidance’s describing how to classify those devices and how to demonstrate equivalence.
The session will describe these new publications to support the EU CE mark of those products and describe what are the main differences with the US market access.
Who should attend?
- Regulatory Affairs
- QARA - Quality Assurance & Regulatory Affairs
- Project Managers
Why should you attend?
To understand the pathway to get these devices on the European market. Get an understanding of how to classify these kinds of devices and understand the differences between EU and US.
Faculty - Ms.Anne-Sophie Grell
Owner of a PhD in Physics and a Master in Medical Physics, I’m working in the Medical Device field since more than 24 years. Starting as a researcher in MRI, taking care of device commissioning and quality control of Radiotherapy Treatment before moving as Quality Assurance and Regulatory affairs manager and then RA Director at Ion Beam Application and at Philips IGTD. Used to register all device classification worldwide especially in EU, US and Asia. Working in consultancy field since May 2021.