News
Readiness Opens Vast European Distribution Opportunities
March 22, 2024
Spectra Medical Devices, a global manufacturer of made-to-spec procedural needles and a distributor of complementary medical instruments, supplies, and pharmaceuticals, today announced that it has secured European Union Medical Device Regulation (EU MDR) certification for its entire range of radiofrequency (RF) needles.
The new EU MDR CE marking recognizes Spectra’s commitment to quality and exacting standards. The EU MDR includes product-specific requirements that exceed ISO 13485 organizational standards for medical device manufacturers to ensure the safety, performance, and quality of medical devices in the European market. With the CE marking, Spectra is now able to sell and distribute products in the European market.
“We are fiercely dedicated to quality standards, and we are proud to have received this recognition of our commitment to clinical safety and impeccable product performance,” said Chad Nikel, President and CEO of Spectra Medical Devices. “We’ve long been recognized for our precision procedural needles, and we are thrilled to be able to introduce them to the European market.”