Certification of Class D devices present additional challenges for manufacturer’s due to the additional requirements for these high-risk devices.
The challenges are further complicated because the infrastructure required in the IVDR is not fully in place. While notified bodies are moving forward with certification of these devices, the path forward and current state of play can be confusing. The targets seem to be constantly changing, making it difficult to prepare for certification of these devices.
In this Live! show we discuss:
- Current status on EURLs and draft common specifications
- What steps notified bodies are taking in lieu of EURLs
- What can you do to be prepared for your technical review
- And much more, including answering your questions!
Sign up to watch the Live! show on demand.
Panelists:
- Margot Borgel – Director, IVD Intelligence & Innovation
- Bethany Chung, Ph.D., RAC – Principal Regulatory Scientist
- Lindsay Wright – Senior Consultant / Capability Manager
- Nancy Morrison, RAC – Vice President, Intelligence & Innovation (moderator)
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