Further, in Article 16 Cases in which obligations of manufacturers apply to importers, distributors, or other persons, it is stated in point 3 that distributors shall ensure to have in place a quality management system. The quality management system shall cover, among others, procedures which ensure that the translation of information with the manufacturer is accurate and up-to-date, and procedures ensuring that the distributor is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with this Regulation.
Also, manufacturers need to be in compliance with harmonized standards published by the Offical Journal of European Union as described in Article 8. On that list, the only standard that covers the quality management system is ISO 13485:2016 so it is expected that all manufacturers have implemented this standard.;