Brexit – Placing devices on the UK market
MDR – Status update ITD products
Wednesday, 16th June 2021, 4pm – 5pm CET, Microsoft Teams
Part I: Brexit – Placing devices on the UK market
Expert: Ronald Boumans of Emergo by UL
The United Kingdom has left the EU and that has consequences for placing devices on the UK market. Until 1st July 2023 CE-marking is accepted, but from that date UKCA marking will apply. Manufacturers should prepare for that. Ronald Boumans of Emergo by UL will provide information on the latest news regarding the UKCA marking, development of specific UK legislation and what can be done to best prepare and how to manage current uncertainties regarding this transition.
Part II: MDR – Status update ITD products
Expert: Gerhard Bumeder of ITD GmbH
MDR is mandatory - MDD is history. The deadline was May 26th 2021. Gerhard Bumeder will give you detailed insights about ITD´s implementation of the MDR. Mr. Bumeder will also show you where and how we can support you around the topic of MDR and what we do to make the registration easier and to place the products on the market faster.
Use the knowledge advantage immediately in your daily work!
Ronald Boumans, Emergo by UL Program manager, European Regulatory Affairs
Ronald Boumans has been working with Emergo since 2013. He is a proven expert on the transition to the new Medical Devices Regulation (MDR) for manufacturers of medical devices. Ronald is now involved in the effects of United Kingdom leaving the EU. He represents Emergo as board member of the UK Responsible Person Association (UKRPA). He is one of the leading authors of regulatory white papers and blogs published on the Emergo website.
Website Emergo by UL: https://www.emergobyul.com/
Gerhard Bumeder, Director Quality & Regulatory Affairs of ITD GmbH
Gerhard Bumeder is responsible for Quality Management and Regulatory Affairs at ITD GmbH. Together with his team, he ensures the regulatory, safety and quality standards of the medical equipment carts and support arms as well as all processes. He and the ITD team are well prepared to support worldwide approval and sales processes from regulatory perspective.
Website ITD: https://www.itd-cart.com/