MDR compliant
OCT 19, 2023
Gold Anchor is now MDR compliant! Years of diligent regulatory work have proven to pay off!
The Medical Device Regulation (MDR) is a set of regulations established by the European Union to ensure the safety and effectiveness of medical devices within the EU market. Officially known as Regulation (EU) 2017/745, it replaced the Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD) in an effort to modernize and strengthen the regulatory framework for medical devices. While the regulation imposes stricter requirements on manufacturers, it is intended to enhance patient safety and increase transparency and accountability within the medical device industry.
To view the certificate, visit our order page.
Johnny Mattebo
COO