The new EU Medical Device Regulation (MDR) (2017/745) will enter into application on 26 May 2020. It was published on 5 May 2017, following a years-long revision process.

Review Of US Medical Device Regulation Published Date: January 10, 2008 Source: InHealth: Institute for Health Technology Studies Summary: A review of the background, mission and statutory ...

The European Union''s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed.

Center for Devices and Radiological Health director Dr. Jeffrey Shuren strongly refuted findings from a recently study that said more than three-quarters of the cost to bring a medical device from ...

Former U.S. President Donald Trump signed proclamations that provide a two-year reprieve from certain Biden-era EPA ...

Items Tagged with 'Medical Device Regulation' ARTICLES. Stereotaxis receives CE mark certification for devices in Europe. May 31, 2024. By Shani Alexander. No Comments. Stereotaxis Inc. recently ...

Dublin, Jan. 29, 2025 (GLOBE NEWSWIRE) -- The "Medical Device Regulatory Affairs Market Size, Share & Trends Analysis Report By Type, By Service Provider, By Service, By Region, And Segment ...

Received Medical Device Regulatory Approval in April 2022 NASH (Nonalcoholic steato-hepatitis) App currently in development and undergoing clinical trials with the University of Tokyo Hospital ...

Activities related to medical devices in the People’s Republic of China (PRC), including their manufacturing, marketing, distribution, and sale, are mainly regulated by the Regulations on ...

South Korea’s medical device market is rapidly expanding, driven by technological innovations and increasing healthcare demands. As the market grows, understanding Korean medical device regulations is ...