“ENHANCING YOUR EXPORTS TO EUROPE FOR MEDICAL DEVICES: LEGISLATIONS & CERTIFICATION” Webinar

The SMF together with EEN Singapore organised a Zoom webinar session on 17 December 2020 to provide insights, analysis and tips on how to export medical devices and diagnostic test kits into the European Union (EU) as well as to share the legislations and certifications involved in exporting to Europe. Information and procedures needed to acquire the mandatory ‘Confirmite Europeenne’ (CE) marking when exporting to the European Economic Area (EEA) were also shared during this webinar. This webinar was proudly supported by EEN Partners from Occitan Chamber of Commerce and Industry (CCI Occitanie), CCI Centre-Val de Loire, and Regional Agency of the Loire Valley (Solutions&co). Ms Emilie Vicq, European Regulation and Policies, and Wendy Amada, European Regulation and Policies Advisor gave a short presentation on understanding the CE marking requirements and the EU legislative framework.

Ms Emmeline Lam, a Senior Director at the SMF delivered the welcome address and gave Singapore companies a better understanding of the requirements of the Medical Device Directives or Regulations, as well as their linkage to the European requirements for CE Marking on commercialising products.

European partners share about legislations and certifications for exports to Europe

During the webinar, the European partners shared how the CE Marking apply to medical devices and IV, as well as operators involved and their legal responsibilities. They also shared the Conformity assessment which covers Notified Body, Technical Documentation Requirements, Conducting Clinical Investigations and Clinical Evaluations. The webinar concluded with a Q&A Session moderated by Gwenaëlle Godet, Project Manager European Standards & Regulations, where she answered questions regarding the EU Medical Devices Regulations together with her team. More than 200 participants comprising SMF members, representatives from fellow Trade Associations and Chambers (TACs), foreign chambers as well as senior management of companies, attended this webinar.

Click on this link to watch the live recording of the webinar! 

https://www.youtube.com/watch?v=gWQfyEvsAYY&t=121s&ab_channel=SingaporeManufacturingFederation