Sahajanand Medical Technologies Receives EU MDR Certification for Supraflex Cruz and Product Family, Reinforcing Global Compliance and Patient Safety

Sahajanand Medical Technologies Limited (SMT), a leading global manufacturer of cardiovascular medical devices, today announced that it has received certification under the European Union Medical Device Regulation (EU MDR 2017/745) for Supraflex Cruz and its product family. SMT is a leading player in India’s drug-eluting stent market and ranks among the top five companies in key European markets, including Germany, Spain and Poland.

The certification follows the conformity assessment process established under EU MDR 2017/745 including assessment of SMT’s technical documentation, clinical evaluation and quality management system. Together with SMT’s existing ISO 13485 quality management system and MDSAP certifications, the EU MDR certification confirms that Supraflex Cruz has successfully undergone assessment against the EU MDR’s stringent requirements for safety, performance and clinical evidence.