Poly Medicure has received Medical Device Regulation (MDR) certification for 54 of its products, covering medical specialties including infusion therapy, vascular access, renal care, urology, surgery and wound care, transfusion systems, anaesthesia and respiratory care, gastroenterology, and diagnostics. The MDR certification confirms that these products meet the safety, quality, and regulatory standards set by the European Union.
Rishi Baid, Joint Managing Director of Poly Medicure, said, “Polymed has been the largest exporter of consumable medical devices for over a decade now. The MDR certification demonstrates that our products not only meet but exceed the most stringent safety and quality standards. We are steadfast in our commitment to these principles, which are at the core of our growth and success. With Europe already contributing half of our export revenue, this certification will further strengthen our presence and reputation in the European market. It is a testament to our focus on quality, innovation, and customer satisfaction.”
An MDR certificate verifies that a medical device complies with the European Union’s Medical Device Regulation. This legal framework governs the production, distribution, and marketing of medical devices within the EU, ensuring compliance with safety, quality, and performance standards. The certification enhances transparency and patient safety within the European Economic Area.
The MDR certification further reinforces Poly Medicure’s position as a global medical device manufacturer, aligning with international regulatory requirements and expanding its presence in the European market.
