Mercury Medical CPR Manual Resuscitation Products Are Now Available in the EU
Mercury Medical recently received MDR CE Mark Certification for their CPR manual resuscitation line. This certification ensures the quality system is in accordance with Regulation (EU) 2017/745 allowing for CPR product line sales in the European market. The EU Medical Device Registration (MDR) replaces the EU’s Medical Device Directive (93/42/EECI) that went into effect in May of 2021. According to the European Commission, (EC), no existing requirements have been removed but new requirements have been added to the MDR. Several additions include:
- Greater emphasis placed on life-cycle approach to safety
- Increased control and monitoring by national competent authorities and the EC
- Reclassification of devices, wider scope of devices
- Coverage of internet sales of medical devices
- Introduction of clinical evaluation consultation procedure
- New Unique Device Identification system with enhanced traceability and post-market surveillance
- Increased transparency with clinical studies and devices
A statistic from July 18th states 85% of MDR Certificates have not been issued transitions from MDD. This means there is a huge backlog and certification is taking 13-18 months.1.
John Gargaro MD, President and CEO at Mercury Medical, states: “This is a HUGE milestone requiring a tremendous amount of resources to achieve MDR certification. This important work allows EU access to clinically differentiated resuscitation devices including a small adult version for assisting clinicians with their lung ventilation protection strategies. This critical certification assures we maintain global presence.”
About Mercury Medical
Mercury Medical is dedicated to delivering clinically differentiated critical care technology that saves lives throughout the world. The company is recognized as a leading provider of cutting-edge technology in the acute care and emergency markets both in the United States and globally. For over 58 years clinicians have relied on Mercury Medical as their resource for bringing a legacy of innovative products to critical care areas of neonatal, anesthesia, respiratory and EMS markets in over 60 countries. Mercury Medical’s high-quality standards include ISO 13485, MDR, MDSAP and ISO 9001 certifications.
For more information:
Contact Deb Olson | Phone (727) 573-4980 | E-mail Address: email@example.com
- Taylor, N. 2022, ‘Notified bodies have yet to issue MDR certificates for 85% of legacy airway devices survey’ MEDTECHDIVE, 18 July, accessed 18 July 2022, https://www.medtechdive.com/news/legacy-devices-lack-mdr-certificates-medtech-europe/627439/