Roles and responsibilities in the Medical Device and IVD Regulations
The new Medical Device and In-Vitro Diagnostic Regulations are expected to be adopted in the first half of 2017. Within the new Regulations articles 10-15 outline the roles and responsibilities of the various actors involved in the manufacture and supply of products into Europe.
The changes from the current Directives are substantial and will affect all companies within the supply chain including:
Changes include, verification of the Declaration of Conformity, Technical Documentation, demonstration of conformity of the devices, involvement in the Post Market Surveillance, Unique Device Identifiers, labelling and requirements for a Person responsible for regulatory compliance. What will companies need to do, and when? All companies must plan and prepare for the new rules because EU law does not allow grandfathering of devices, so every device must be certified under the new rules in the transitional time frames provided.
This webinar will help you to consider what actions you need to start now to be prepared for the change in requirements; the webinar will outline the actions required, for each of the roles outlined in the new Regulations.
Suzanne Halliday is Head of BSI Medical Device Notified Body. She has twelve years of experience within the Notified Body. For eight years Suzanne led the Orthopeaedic and Dental team, with responsibilities for aspects of EN ISO 13485 and CE Marking for all global clients. The team was also responsible under numerous Mutual Recognition Agreements for aspects of compliance in Canada, USA, Japan, Taiwan and Australia.
In her current role, she continues to audit manufacturers' quality systems and technical documentation while leading the global Medical Devices team.
Prior to Suzanne's work at BSI she completed a Bachelor Degree and Masters in Science (University of Waterloo) and a Doctorate in Engineering (University of Oxford).
Suzanne has worked in orthopaedic hospitals in Australia, Canada, Japan, UK and the USA, testing joint replacement implants and spinal and fracture fixation systems. She has also lead clinical investigations on orthopaedic implants.