MVP

According to the MDR, Article 8 - Use of harmonized standards, it is the manufacturer's obligation to prepare and manufacture their medical device according to the harmonized standards published in the Official Journal of the European Union. On that list is more than 300 different standards considering how the certain medical device must be prepared, The only standard that is on that list considering the quality management system is ISO 13485:2016. Therefore, ISO 13485 is necessary to be implemented.   

For more information, see: 
EU MDR Article 8 – Use of harmonised standards - https://advisera.com/13485academy/mdr/use-of-harmonised-standa