Seminar on "Update on European Medical Device Regulation (MDR) (2017/745)"

7 August 2019


The new European Medical Device Regulation (MDR) 2017/745 has been published to replace the existing Medical Device Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC). The MDR entered into force on 25 May 2017, marking the start of the transition period for manufacturers selling medical devise into Europe.

In view of this, Hong Kong Medical and Healthcare Device Industries Association (HKMHDIA) and BSI co-organized a seminar on Update on European Medical Device Regulation (MDR) (2017/745)". Our medial device expert, Mr Lane Ji introduced the key areas to note for the MDR transition challenges and addressed the changes on the certification requirements of MDR.


 Welcome speech by Mr Samson Tsoi, Vice Chairman, HKMHDIA


Opening speech by Ms Davis Leung, Senior Business Development Manager, BSI Hong Kong


Presentation by Mr Lane Ji, Healthcare Director, BSI China