Important Changes to the Draft European IVD Regulation
1 Hour Video | Stefan Burde, BSI Americas
In June 2015, the European Council published its much anticipated consolidated draft of the proposed IVD Regulation. This newest draft differs from the previous version in several important ways. These changes will have a significant impact on manufacturers’ plans for implementation of the new regulation. The Commission clarified and re-interpreted several important aspects of the previous proposal, and strengthened Notified Body oversight of lower-risk class devices.
The presentation will discuss the following topics:
- Rationale and expected timeline for implementation
- Major changes in the Council’s draft
- Risk based classification of devices
- Routes to conformity
- Clinical expectations
- Economic Operators
Participants that will find this webinar most beneficial will be those involved in diagnostic companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Legal Counsel
- Compliance Officers
Stefan Burde, PhD
IVD Product Expert
Dr Burde is an IVD Product Expert in the In Vitro Diagnostics Notified Body at BSI Healthcare. He received his PhD in Pathology from the University of Rochester and did post-doctoral work at Los Alamos National Laboratory. He has over 13 years of experience in the In Vitro Diagnostics Industry in the development and manufacturing of IVDs for US, European and global markets. His prior positions include Bayer Biological Products, bioMérieux, and Advanced Liquid Logic, as well as independent consulting work for IVD start-ups.
He joined BSI in 2014 as part of BSI’s expansion of the IVD team to address the growing need for Quality and Technical assessments by the IVD Notified Body in response to the upcoming changes to the European In Vitro Diagnostics Regulation.