The EU MDR regulations do not incorporate In Vitro Diagnostic Regulation (IVDR); this IVDR equipment is governed by a separate EU regulation 2017/746. However, Article 1 (point 7) of the MDR regulation clarifies the relationship between the IVDR regulation and the EU MDR regulation: if a device has both IVDR components and other medical device components, then the IVDR parts of any device are governed by the 2017/746 regulation, but the remainder of the device is covered by the MDR EU regulation.
In vitro medical devices are devices intended to be used for diagnostic, monitoring, or compatibility measurement of specimens outside of the human body. The new EU MDR regulations includes requirements for these types of products.
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
