ISO have released a new standard: ISO 20417:2021.
ISO 20417 provides clear and comprehensive criteria for the general information that manufacturers need to supply with their medical devices and IVD devices, including requirements for the identification, markings and labels on a medical device or accessory.Â
ISO 20417:2021 is on the list of standards that will be harmonised under the EU Medical Device Regulation (MDR), as it is intended to replace the existing EN 1041:2008+A1:2013. So all medical device manufacturers should make themselves familiar with ISO 20417 and start applying its requirements now.Â
Our article gives an overview of the new standard. We break down the differences between the new standard and EN 1041 to help you simplify your conformity process.
Scope of 20417
The new standard’s primary goal is to provide a central source of generally applicable information requirements. As such, there are several familiar regulations and documents that it considers:
- MDR (EU)) 2017/745 The general safety and performance requirements (GSPRs) for the information supplied by the manufacturer of a medical device of the EU Medical Devices Regulation
- IVDR (EU) 2017/746 The GSPRs for the information supplied by the manufacturer of a medical device according to the IVD Medical Devices Regulation
- ISO 16142-1:2016 The general essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
- IMDRF/GRRP WG/N52:2019 Principles of Labelling for Medical Devices and IVD Medical Devices on the information supplied by the manufacturer of a medical device
- IMDRF/GRRP WG/N47:2018 Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
The challenge the new standard faced was integrating these requirements and providing clarity on the various sections that had previously been vague and open to interpretation.
As such, the new standard aims to:
- Set general requirements for information that the manufacturers must provide to the user for safe usage of the device
- Avoid duplication of information which occur in multiple product specific standards.
What is covered by ISO 20417?
As a result of the sheer amount of information to include, ISO 20417 is a substantial and lengthy standard at over 80 pages of content.
Crucially, the standard outlines the information that must be provided by the manufacturer to ensure safe use of the device or accessory, including information on:
- The transportation and storage of the device
- The repair or maintenance of the device
- The measures or conditions necessary for installation of the device
- The preparation of the medical device for use.
Example requirements of ISO 20417
Some requirements set out in ISO 20417 simply build on the MDR/IVDR requirements, while others expand to supply guidance and clarification.
Some key examples include:
- Label on the device itself or on the packaging
ISO 20417 seeks to supply clarity on the MDR’s guidance: that the label must be on the device itself, unless “this is not practicable or appropriate”, in which case it may be provided on the packaging.
Section 6.1.1. ISO 20417 specifies the only conditions in which the label may be on the packaging:
- The surface material of the device does not allow it
- The dimension of the device does not allow it
- Not supplying the information on the device itself does not lead to risks
Supplying clarity on the conditions in which the label may be on the packaging is useful to ensure uniformity across manufacturers.
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- Date
Section 5.4 states that the date must be given in the format YYYY-MM-DD or YYYY-MM or YYYY.
- Use of symbols on the label
The MDR’s previous guidance faced criticism for ambiguity around the use of symbols on the label. ISO 20417 makes clear that the information on the label can be presented in text or symbol format. However, where symbols are used, they must be taken from specific standards as listed in section 5.2, “Graphical information”.
Why use ISO 20417?
Use of the standard will help medical device manufacturers:
- Enter new markets
- Facilitate trade
- Manage risk
- Expand product information expertise
- Enhance trust in products.
Compliance to ISO 20417 may seem daunting when considering the amount of detail and enhanced cross-functional cooperation needed, however, it is an effective way to prove compliance with all regulatory requirements of information supplied by manufacturers of medical devices.
Next steps
The new standard is a central pillar of the quality management of medical devices.
ISO 20417 is a milestone in harmonising and standardising the labeling of medical devices and accessories, presenting manufacturers with a central source of information and clearer requirements.
To learn more about the core quality requirements for medical device manufacturers supplying the EU, download our toolkit.
Sophie Willink
As Ideagen’s Content Marketing Executive, Sophie produces informative content to provide customers with digestible insights into the world of quality, audit, risk and compliance.
With a background in psychology, Sophie is passionate about understanding human behaviour and the role technology can play in measuring, reporting and improving behaviours to create higher quality business environments.