On April 4, 2021 , the International Organization for Standardization (ISO) published ISO 20417:2021 Medical devices — Information to be supplied by the manufacture, which replaces ISO 1041:2008.
What does the new ISO 20417:2021 change?
Over the years international standards have been updated many times. What is it then that differentiates the new ISO 20417:2021 from the previous versions?
The document covers new requirements for the identification, labels, packaging and marking of medical devices and medical device accessories to be supplied by the manufacturers. It aims to allow “each specific product standard or group standards to focus more concisely on the unique requirements for a specific medical device or group of medical devices” (ISO, 2021) making manufacturers’ lives easier.
However, it does not indicate the means by which the information should be provided.
The main purpose is to set general requirements of what information must be supplied by manufacturers in order to provide users with instructions for the safe use of the device.
In case Competent Authorities impose their own requirements that differ from the ISO standard, the first one takes precedence over the requirements of this document.
Moreover, ISO 20417:2021 contributes to the United Nations Sustainable Development Goals (SDGs), which cover economic growth, social needs, and environmental protection.
What should manufacturers know?
We should bear in mind that the new ISO standard has not been harmonized by the Commission yet. Therefore, manufacturers cannot rely solely on the standard to ensure compliance with the Regulation (EU) 2017/745 on medical devices. It means that both the standard and the MDR should be used together and, whenever a conflict between requirements appears, the MDR prevails.
How can it help medical devices’ manufacturers?
By focusing on the unique requirements for a specific medical device or group of medical devices, the ISO standard facilitates compliance with national legislations. This leads to better product information and risk management, as well as a growth in the trust towards the manufacturer’s products. Overall, the new document makes it easier for the medical devices’ manufacturers to enter new markets.
Kamila Swiatek
Regulatory Affairs Department
11.05.2021
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References:
- BSI. (2021). BS EN ISO 20417:2021 Medical devices – Information to be supplied by the manufacturer. Retrieved on 11.05.2021 from https://www.bsigroup.com/en-GB/standards/BSISO20417-2021/#:~:text=Why%20use%20BS%20ISO%2020417%3A2021%3F%20The%20standard%20aims,specific%20medical%20device%20or%20group%20of%20medical%20devices.
- European Commission. (2019) Single Market Policy, Regulation and Implementation: A Notification under Article 12 of Regulation (EU) No 1025/2012. Retrieved on 12.05.2021 from https://ec.europa.eu/search/?query_source=GROWTH&QueryText=iso+20417&op=&swlang=en&form_build_id=form-6hQ26lEcK01x6D29lJ01HcbS072sbpcxd46cX26x_iY&form_id=nexteuropa_europa_search_search_form
- ISO (2021a). SUSTAINABLE DEVELOPMENT GOALS. Retrieved on 11.05.2021 from https://www.iso.org/sdgs.html
- ISO. (2021b). ISO 20417:2021(en) Medical devices — Information to be supplied by the manufacturer. Retrieved on 11.05.2021 from https://www.iso.org/obp/ui/#iso:std:iso:20417:ed-1:v1:en