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 ...

The European Commission’s Medical Devices Coordinating Group (MDCG) on Monday issued a guidance to help manufacturers classify their devices under the Medical Device Regulations (MDR) before they are ...

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 ...

Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...

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 ...

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min In a warning letter dated Sept ...

Global Medical Devices Outsourcing Market OverviewThe global medical devices outsourcing market is witnessing remarkable ...