Yes, ISO 13485 is basically mandatory for manufacturers of medical devices and in vitro diagnostic devices in the European Union (EU). While it’s not explicitly mandated by EU regulations, compliance with ISO 13485 is harmonized with the requirements of the Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR). Achieving compliance with this standard enables organizations to establish a comprehensive Quality Management System (QMS) that aligns with the demands of MDR and IVDR. This, in turn, allows them to obtain the CE marking, which is obligatory for medical device market access within the EU. Therefore, while not directly mandated, adherence to ISO 13485 is practically essential for manufacturers seeking to operate within the EU market.