It means that both the standard and the MDR should be used together and, whenever a conflict between requirements appears, the MDR prevails. Therefore, manufacturers cannot rely solely on the standard to ensure compliance with the Regulation (EU) 2017/745 on medical devices.
#ISO 14001 STANDARD NEW STANDARD EFFECTIVE DATE ISO#
We should bear in mind that the new ISO standard has not been harmonized by the Commission yet. Moreover, ISO 20417:2021 contributes to the United Nations Sustainable Development Goals (SDGs), which cover economic growth, social needs, and environmental protection. 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. 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. However, it does not indicate the means by which the information should be provided. 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.
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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. What is it then that differentiates the new ISO 20417:2021 from the previous versions? Over the years international standards have been updated many times. On Ap, the International Organization for Standardization (ISO) published ISO 20417:2021 Medical devices - Information to be supplied by the manufacture, which replaces ISO 1041:2008.