Learning Marketplace

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 implemented.

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

Presenters

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 Assurance.

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 Group.