Members are invited to attend this webinar about Regulation (EU) 2017/745 (MDR) and Regulation 2017/746/EU (IVDR), which introduce the unique device identification (UDI) system as a new concept currently being implemented in Europe.
It will take place on Monday 11 September at 2pm to 4pm CEST (Brussels time).
MedTech Europe offers this training opportunity on the basic concepts and general regulatory requirements of the UDI system implementation in Europe:
- Concept of UDI-DI, UDI-PI and Basic UDI-DI
- Assignment of UDI-DI and Basic UDI-DI
- Placement of UDI carrier on devices / packaging
- Recording of UDI in regulatory documents
- Registration and storing of UDI
Participants are welcome to submit their questions in advance to mailto:mregulatory@medtecheurope.org.
The webinar will also include a Questions and Answers session12at the end (to be submitted in written format in the chat).
This webinar is designed particularly to companies in the field of medical technology who have limited resources/training opportunities (e.g. small and medium-size enterprises).
Speakers:
- Tania Pearson – Chair of MedTech Europe UDI WG, Regulatory Systems Director, Medtronic
- Marina Madokoro – Regulatory Affairs Manager, UDI EMEA, Johnson & Johnson MedTech
- Frank Matzek – Vice-Chair of MedTech Europe Notified Body WG, VP Regulatory & Governmental affairs at BIOTRONIK
- Katalin Máté – Coordinator of UDI, EUDAMED and EUDAMED IT Expert Working Groups, Manager Industrial Policies (MDR&IVDR) at MedTech Europe
You can sign-up to the webinar here.
