By Stewart Eisenhart, Emergo Group
EU Regulation 722/2012 requires device manufacturers whose products utilize tissues of animal origin to ensure adequate risk management and controls to prevent spreading certain animal-borne diseases to users of their products. The regulation also requires affected manufacturers to conduct specific risk analysis and management procedures prior to submitting conformity assessment applications under the Medical Devices Directive or Active Implantable Medical Devices Directive.
Furthermore, EU member states must now verify that Notified Bodies active in their jurisdictions have current, up-to-date information regarding any medical devices falling under the new regulation. Notified Bodies, in turn, are now required to evaluate manufacturers’ risk management and analysis processes, control over device materials and production, and whether issues regarding sourcing and processing of animal tissues should be audited during conformity assessments.
Affected manufacturers must comply with the new regulation in order to obtain CE Marking for their devices.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.