IVD Field Safety Notices
We all hope that we will not need to send out a Field Safety Notice on a regular basis;
this makes it particularly important to understand what they are and how they should and
should not be used so that if one is required it can be efficiently and effectively
MEDDEV 2 12-1 rev. 8 Guidelines on a Medical Devices Vigilance System provides some
guidance, the aim of this presentation is to cover the expectations for Field Safety
Notices for IVDs from 3 perspectives, the Competent Authority, Industry and the Notified
Body an also present an opportunity for questions to be asked.
This webinar will cover:
- What is Field Safety Action/Field Safety Notice and when is it required?
- How do I write a Field Safety Notice
- What should I do if I receive a Field Safety notice
Sue Spencer is head of Notified Body at BSI she has 29 years experience
in the IVD industry, and has held positions in R&D, Manufacturing and Quality
Dr Simon Richards is VP Regulatory Affairs EME at Alere International
and Chair of the Regulatory Affairs Working Party at BIVDA, the UK IVD Trade
Association. Simon has over 24 years experience in quality and regulatory covering the
medical device, pharma and IVD sectors.
Stephen Lee is Biosciences Team Manager at MHRA he has over 20 years
experience in the biomedical sector and chairs the European Commission IVD Technical