EN 1041:2008 is the harmonized standard for information to be supplied by medical device manufacturers.
The International Standardization Organization (ISO) has recently published ISO 20417:2021, which will replace EN 1041 under Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and IVDR).
As communicated in earlier newsletter articles, there are no harmonised standards under the MDR and IVDR yet. Also generally, the use of standards is voluntary. Nonetheless, we anticipate that competent authorities and notified bodies will expect to a certain degree that manufacturers adopt this standard in a timely manner.
Source: International Standardization Organization (ISO)