We are pleased to announce that EUROTAPE b.v. entirely works under the regulations (EU) 2017/745 regarding the Medical Device Regulations. The MDR, or Medical Device Regulations, refers to a set of regulations implemented by the European Union (EU) to establish a comprehensive framework for the regulation of medical devices. The MDR replaced the previous Medical Device Directive (MDD) and came into effect on May 26, 2021.
The primary goal of the MDR is to ensure the safety, quality, and efficacy of medical devices while enhancing patient safety and harmonizing regulations across EU member states. The regulations apply to a wide range of medical devices, including surgical instruments, implants, diagnostic equipment, software, and more. The MDR represents a significant shift in the regulation of medical devices, with an increased focus on patient safety, transparency, and accountability. Compliance with the MDR is mandatory for all medical device manufacturers wishing to market their products within the European Union.
Any questions regarding the MDR, feel free to contact us here!