The European Union has recently published the new IVD Regulations which are distinct and separate from the Medical Device Regulations. The revised IVD Regulations have been modified so extensively that it is estimated that whereas now 20% of IVD’s are under EU Regulatory control, when enacted, almost 80% of IVDs will be under regulatory control. This means that many IVD manufacturers will be subject to regulation for the first time. And for those already under regulatory control, more of your product lines may be subject to regulatory control and you may have to reclassify the others.
These changes are significant and will take a herculean effort in some cases to transition. To properly assess the work that needs to be done, UL’s Head of Global Medical Device Services, Sue Spencer took a deep look into the regulations and share her 30+ years of industry IVD experience on how to effectively assess the challenge to transition.
In this 60 minute session, Sue Spencer, Head of Global Medical Device Services, shared her experience on what exactly has changed, what that means for device manufacturers, and how the Notified Bodies will approach the updated requirements.
Specifically, she discusses the following with specific examples:
- Notified Body Designation
- Classification Rules
- Conformity Assessment Routes
- Safety and Performance
- Risk Management
- Clinical Evidence
- Post-market performance follow-up (PMPF)
- In house manufacture
- Unique Device Identification, and more.
This webinar was delivered live on July 12, 2016 in front of over 220 registered sites and includes a 13 minute Q&A session. Please fill in the form and we'll send you a link to the recording.
Presenter: Sue Spencer, Head of Global Medical Device Services at UL
Sue Spencer has over 30 years’ experience in the IVD industry where she has held positions in R&D, Manufacturing and Quality Assurance; she has worked in the Notified Body arena since the initial introduction of the IVD and Medical Devices Directives and is now involved with the development of the new regulation.
Sue has over 10 years’ experience working for several Notified Bodies; she currently chairs the European IVD Notified Body Working Group coordinating the notified body responses to the changing regulatory environment. Sue also participates in the Commission IVD Technical Work Group and chairs a sub group preparing guidance on the revised IVD classification.
In the past Sue has worked as a consultant establishing her own consultancy before joining Abbott Diagnostics Division where she was Manager for International Quality Systems and Risk Management for the Division for over 6 years.
Sue is an experienced tutor on a variety of topics including the IVD Directive, ISO 13485 and risk management.