HuaKe Run’s entire line of vertebroplasty products has officially obtained EU MDR certification.

CE MDR Certification

CE marking is the European Union’s product safety certification. Medical devices exported to any of the 30 member states of the European Economic Area (EEA)—which comprises the European Union (EU) and the European Free Trade Association (EFTA)—are required to obtain CE marking for medical devices.

Since May 2021, the European Union has required medical device manufacturers to comply with the EU Medical Device Regulation (MDR) (2017/745), which replaces the previous Medical Devices Directive (MDD) (93/42/EEC), in order to obtain CE marking approval. Under the new regulations, the EU has raised the threshold for notified bodies, emphasized the importance of enhancing the safety, performance, and documentation requirements for medical devices, and strengthened the post-market surveillance system for devices; therefore, European Union The MDR certification cycle has lengthened, and the difficulty of obtaining certification has increased substantially.