Medical devices that want to be put on the EU market must be prepared according to the requirements from the Medical device regulation (MDR, 2017/745). In this regulation are requirements both how the medical device must be designed, constructed, produced, and tested to prove its safety and performance.
For all medical device manufacturers, it is mandatory to have implemented a quality management system (Article 10). Also, manufacturers must prove compliance with a list of harmonized standards that are published by the European Commission in the Official Journal (Article 8). There are more than 300 different standards on that list, but the only standard that covers the quality management list is ISO 13485:2016. That is why it is expected for the manufacturers on the EU market to have implemented ISO 13485:2016.
Besides the quality management system, each medical device must have prepared technical documentation according to Annex 2 and Annex 3 of the MDR.
In ISO 13485:2016 there is requirement 7.1 Planning of product realization that asks form the manufacturers to document one or more processes for risk management in the product realization. ISO 14971:2019 is the standard that covers requirements regarding risk management, especially for medical devices.