New standard on information to be supplied by the manufacturer of medical devices

ISO 20417:  Medical devices — Information to be supplied by the manufacturer - nears completion

ISO 20417 sets out requirements for the identification, marking and labels on a medical device or accessory, and the information necessary to accompany the device or accessory. This standard aims to provide a central source of the common, generally applicable requirements. This allows each specific  product standard, or standard for a group of products, to address the particular requirements for products within its particular scope. If there is a conflict with a particular standard for a product or group of products,  the requirements of the particular standard takes precedence over requirements of ISO 20417.

ISO 20417 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general  aspects for medical devices. ISO TC/210 is also responsible for key standards such as ISO 13485, Medical devices — Quality management systems —Requirements for regulatory purposesand ISO 14971, Medical devices — Application of risk management to medical devices.

ISO 20417 is intended to replace EN 1041:2008+A1:2013, Information supplied by the manufacturer of medical devices.  ISO 20417 is listed in the draft standardization request from the European Commission to the European Standards organizations.

ISO 20417 has been prepared taking account of requirements and recommendations in several documents, including: 

• the International Medical Devices Regulators Forum (IMDRF) document on the information supplied by the manufacturer of a medical device in the Essential Principles of Safety and Performance of medical devices and in vitro diagnostic (IVD) medical devices
• the IMDRF document on principles of labelling for medical devices and IVD medical devices
• ISO 16142-1:2016 on the application of the essential principles of safety and performance on the information supplied by the manufacturer of a medical device
• the general safety and performance requirements (GSPRs) for the information supplied by the manufacturer of a medical device of the EU Medical Devices Regulation (MDR)
• the GSPRs for the information supplied by the manufacturer of a medical device according to the IVD Medical Devices Regulation (IVDR)

An informative annex of ISO 20417 provides cross references between the standard and the requirements or recommendations in the source documents.

ISO 20417 covers requirements for information:

• to be supplied on the label
• to be provided on the packaging
• in the instructions for use and technical description
• otherwise required to be supplied with the medical device or accessory

Technical description is a term for all the data that is essential for safe use, transport and storage, maintenance or repair, and measures or conditions necessary for installing the medical device and preparing it for use.

ISO 20417 includes requirements organized in the following structure:

• Clause 4 contains general process requirements
• Clause 5 underpins the information supplied by the manufacturer such as how to:
• express units of measurement
• identify languages and countries
• express dates
• express addresses
Clause 5 also addresses identification of medical devices and accessories, such as:
• catalogue number
• unique identification of software version
• production control
• a consistent indication of use/reuse
• indication of sterility
• Clause 6 addresses the accompanying information of medical devices and accessories. This includes the requirements for the packaging,  the label and marking of medical devices and accessories, as well as the instructions for use and technical description.

ISO 20417 will be an important standard for manufacturers of medical devices and writers of medical devices’ standards. Watch out for its progress to publication.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development