ISO 20069-2019 PDF

Full title and description

ISO 20069:2019 — Guidance for assessment and evaluation of changes to drug delivery systems. This International Standard provides a structured approach for assessing planned changes to drug delivery systems that are integral with, packaged with, or cross‑labelled for use with a specified medicinal product, covering the device lifecycle from registration and clinical studies through end‑of‑life.

Abstract

This document gives guidance on how to determine the nature and impact of changes to drug delivery systems (including needle‑based injection systems, aerosol drug delivery devices and needle‑free injectors), the associated assessments and evaluation activities needed to support continued safety, performance and regulatory compliance, and the extent to which related software changes are relevant. It clarifies examples of changes, limits of applicability and interfaces to other device standards.

General information

• Status: Published (confirmed in ISO review process)
• Publication date: 5 August 2019
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.040.01 (Medical equipment)
• Edition / version: Edition 1 (2019)
• Number of pages: 36

Key bibliographic and lifecycle information as published by ISO (status, date, edition, ICS and page count).

Scope

ISO 20069:2019 applies to the assessment and evaluation of planned changes to drug delivery systems that are either integral with, packaged with, or cross‑labelled for a specified medicinal product. It covers the device lifecycle from pre‑market/registration and clinical studies through production, post‑market and end‑of‑life. The standard specifically addresses needle‑based injection systems, aerosol delivery devices and needle‑free injectors (with notes on relevance to other device types), and indicates where other standards such as the ISO 11608 series, ISO 20072 and ISO 21649 provide related or more specific requirements. The document does not set the objective for a proposed change nor prescribe every possible downstream activity that may be required.

Key topics and requirements

• Framework for change assessment and evidence evaluation across the device lifecycle.
• Classification of changes by potential impact on safety, performance and user interaction.
• Guidance on required risk assessment, verification, validation and human factors considerations resulting from changes.
• Consideration of software changes to the extent they affect device behavior or user interaction.
• Examples of typical changes (design, materials, manufacturing process, packaging, labelling, software) and recommended assessment activities.
• Cross‑references to device‑specific standards (ISO 11608 series, ISO 20072, ISO 21649) where applicable.

These topics form the core approach ISO 20069 recommends for demonstrating that a change does not adversely affect the combined product/device‑drug configuration.

Typical use and users

Primary users are pharmaceutical companies and medical device manufacturers that develop, produce or supply drug delivery systems for specific medicinal products. Secondary users include regulatory affairs and quality assurance teams, design and R&D engineers, human factors specialists, clinical evaluators, notified bodies and competent authorities assessing change dossiers, and supply‑chain partners responsible for manufacturing or packaging changes.

Related standards

ISO 11608 series (needle‑based injection systems), ISO 20072 and ISO 21649 are noted as related standards for specific device families; ISO 20069 is intended to be used alongside these and other regulatory and device‑specific standards to define the full set of assessment and verification activities required after a change.

Keywords

drug delivery systems, change control, lifecycle, combination product, risk assessment, verification, validation, human factors, regulatory submission, device‑drug combination

FAQ

Q: What is this standard?

A: ISO 20069:2019 is an International Standard providing guidance for assessment and evaluation of planned changes to drug delivery systems that are integral with, packaged with, or cross‑labelled for use with a specified medicinal product.

Q: What does it cover?

A: It covers methods to classify changes by impact, recommended assessment activities (risk assessment, verification, validation, human factors), applicability to certain device families (needle‑based injectors, aerosol devices, needle‑free injectors) and how to consider related software changes; it also points to other device‑specific standards for additional requirements.

Q: Who typically uses it?

A: Pharmaceutical and medical device manufacturers, regulatory affairs and quality teams, design/R&D and human factors specialists, and conformity assessment bodies involved in reviews of change notifications or submissions.

Q: Is it current or superseded?

A: As published in August 2019, ISO 20069:2019 is the first edition. According to ISO lifecycle information the standard is published and has been through periodic review; users should check the ISO catalogue or their national standards body for the latest confirmation or amendment history when preparing regulatory submissions.

Q: Is it part of a series?

A: It is a standalone guidance document intended to be used in conjunction with device‑specific series (for example the ISO 11608 series for needle‑based injectors) and other applicable standards such as ISO 20072 and ISO 21649 for related device types.

Q: What are the key keywords?

A: drug delivery, change assessment, combination product, lifecycle, risk, verification, validation, human factors, regulatory.