What is ISO 20417 about?
ISO 20417 specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory.
ISO 20417 includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information but it does not specify the means by which the information is to be supplied.
NOTE: Some authorities with jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory. Specific requirements of medical device product standards or group standards take precedence over the requirements of this document.
Who is ISO 20417 for?
ISO 20417 on information to be supplied for medical equipement is applicable to:
- Manufacturers of medical device and accessories
- Pharmaceutical companies for auditing
- Quality and compliance departments in the medical industry
- Regulatory bodies
Why should you use ISO 20417?
Information provided by medical device manufacturers is very important for pharmaceutical companies to ensure product end-users receive effective and quality-assured products.
ISO 20417 provides the requirements for the identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information.
The aim of ISO 20417 is to serve as a central source of these common, generally applicable requirements, allowing each specific product standard or group standard to focus more concisely on the unique requirements for a specific medical device or group of medical devices.
As a manufacturer, the information on multiple parameters to be provided as per ISO 20417, will enable you to improve specification of your product, thereby enhancing its global acceptance.
Moreover, ISO 20417 will help you avoid potential damages and risks pertaining to your products resulting in increased consumer reliability and confidence. More importantly, adhereing to ISO 20417 ensures products and services undertaken by healthcare providers is safe and effective.
ISO 20417 contributes to UN Sustainable Development Goal 3 on ensuring healthy lives and promoting well-being for all at all ages