The Singapore Manufacturing Federation (SMF) in partnership with Enterprise Europe Network Singapore (EEN Singapore) and supported by Occitan Chamber of Commerce and Industry (CCI Occitanie), CCI Centre-Val de Loire and Regional Agency of the Loire Valley (Solutions&co) will be organising a Zoom webinar on “Enhancing Your Exports To Europe For Medical Devices: Legislations & Certification” on Thursday, 17th December 2020 from 1630HR – 1800HR Singapore Time / 0930HR – 1100HR Central European Time. Admission to this online session is complimentary for all guests.
This online session aims to provide insights, analysis and tips on how to export medical devices and diagnostic test kits into the European Union (EU) as well as understand 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) will also be shared during this webinar.
The program of the online session will cover the following:
- Understanding CE marking requirements:-
- Why CE Marking: understanding EU legislation framework
CE Marking applied to medical devices and IVDMID:-
- The definition and classification of a “medical device”
- Operators involved and legal responsibility
- Conformity assessment: Notified Body; Technical Documentation requirements; Conducting clinical investigations /clinical evaluations etc.
- CE Marking affixing and labelling
To facilitate arrangements, please register via the link and complete all the details required: https://zoom.us/webinar/register/WN_OO4gGggHTkW6H5SED6cuKw