Standards Development

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, drugdevice, biological drugdevice, or drugdevicebiologic). 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 drugbiologic 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.

Purpose

Combination products (CPs) are a growing area and there’s a gap in existing guidance. In particular there are separate risk management protocols for the constituent components that make up a CP (ie., medical devices, pharmaceuticals/biologics). Although there are national documents that address risk management for CPs, there is currently no international document addressing this topic. This project will allow international discussion among all stakeholders(including other ISO technical committees and ICH) on best practices in the joint implementation of ICH and ISO risk management systems when developing CPs. This project will help prevent the proliferation of conflicting national solutions in this area. (There is no intent to develop an alternative risk management process for these products.) Because the scope of this work covers a wide variety of combination products and addresses the application of existing risk management protocols (ISO 14971 and ICH 9), ISO TC/210 is the appropriate committee.