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GCE Healthcare Receives MDR Approval for Medical VIPR Products 29 April 2024

The roster of MDR-certified GCE Healthcare products continues to expand. We acquired Medical Device Regulation (MDR) certification for our renowned medical VIPR (Valves with Integrated Pressure Regulators) products.

This certification represents a significant milestone in our pledge to ensure the safety and effectiveness of medical devices across Europe.

Currently, the MDR certification encompasses a selection of GCE's premium products, including MediVital, MediVital E, MediVitop, and other VIPRs for selected customers, joining the list with the previously approved Medimeter® Tube Flowmeter. GCE's steadfast commitment to excellence assures stakeholders that this roster will continue to grow.

The Medical Device Directive (MDD) will be replaced by the EU Medical Device Regulation (MDR), which came into effect on May 26, 2021. This transition underscores the industry's heightened focus on enhancing safety and performance standards. Notably, the MDR places increased emphasis on distributor accountability within the European Economic Area, fostering supply chain transparency to uphold patient safety.

GCE Healthcare embraces the challenges posed by the MDR and recognizes the pivotal role it plays in maintaining transparent supply chains, thus safeguarding patient welfare. We remain steadfast in our commitment to delivering exceptional healthcare solutions while upholding the highest standards of safety and efficacy.

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