Mercury Medical CPR Manual Resuscitation Products Are Now Available in the EU

CLEARWATER, FL / ACCESSWIRE / July 27, 2022 / 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) thatwent 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 safetyIncreased control and monitoring by national competent authorities and the ECReclassification of devices, wider scope of devicesCoverage of internet sales of medical devicesIntroduction of clinical evaluation consultation procedureNew Unique Device Identification system with enhanced traceability and post-market surveillanceIncreased 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 protected]

SOURCE: Mercury Medical

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