The European Commission’s Medical Device Coordinating Group (MDCG) has revised several documents addressing the classification of products under the Medical Device Regulation (MDR) and the In Vitro ...

In five separate consultations opened on Wednesday, Australia’s Therapeutic Goods Administration (TGA) proposed new medical device classifications in line with the EU medical device regulation (MDR).

FDA has finalized guidance on medical device classification product codes that are used to assist in accurate identification and tracking of current medical devices, and for easy reference to ...

FDA's Center for Devices and Radiological Health (CDRH) issued a request for public comment on December 5, 2025, seeking feedback on the distinct classification of existing medical device accessories ...

After enactment of the Medical Device Amendments of 1976, which established three regulatory classes for medical devices, the Food and Drug Administration (FDA) has been required to classify all ...

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...

A medical device is any appliance, apparatus, software, material, or other articles, which may be used in isolation or combination (as defined by the manufacturer) by individuals for a medical purpose ...