ISO/NP TS 25694

Risk Management for Combination Products ISO/NP TS 25694

Scope

This document provides recommendations on the concurrent application of ISO 14971 and ICH Q9 risk management principles and processes during development and marketing of combination products that include a device constituent part (eg, drug−device, biological drug−device, or drug−device−biologic). These recommendations are intended to inform the adoption and application of established risk management processes during all phases of the lifecycle of combination products. The recommendations and processes described in this document are intended to assist manufacturers of combination products in identifying hazards associated with the combination product, assessing associated risks, selecting options for controlling these risks, and monitoring the effectiveness of the implemented controls.
The document does not address drugs, biologics, or devices that are not part of a combination product, nor does it address drug−biologic combination products, as risk management considerations for these are similar to those for drugs or biologics alone. Additionally, the document also does not address topics outside the realm of risk management for combination products.