Medical device manufacturers implement risk management following ISO 14971:2007. In August 2012, the European Union (EU) published a regional variation, EN ISO 14971:2012, which informs of situations where the product directives are more restrictive than the risk management standard. There are seven content deviations that apply to the Medical Device Directive (MDD). In each case the wording in the MDD is more restrictive than the requirements of ISO 14971:2007, so the MDD governs. Manufacturers who put the CE Mark on a medical device must bring the risk management file into compliance with the harmonized standard.
Attendees will learn:
- The substance of the seven content deviations – ensure success by avoiding risk
- An explanation of how content deviation requirement differs from the international standard
- The expected content of an ISO 14971:2007 risk management file
- Practical steps to update the risk management file to EN ISO 14971:20012
- The Team-NB recommendation for Notified Bodies to evaluate a risk management file.