Version 4 of the Manual on Borderline and Classification for Medical Devices was published in September by the European ...
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a consultation period calling on the public and private bodies for input as it looks to make changes across four key ...
Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "EU MDR and IVDR: Key Updates and Compliance Strategies for 2025 (Aug 6, 2025)" training has been added to ResearchAndMarkets.com's offering. The EU ...
A new EU amendment aimed at avoiding shortages of vital in vitro diagnostics (IVDs) without compromising safety has been welcomed by an expert in medical device regulation. The amendment to the In ...
Following their adoption by the European Parliament in April 2017, the final versions of the Medical Devices Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR") were published in the ...
In late July 2025, the UK government published its response to a consultation held between November 2024 and January 2025 about international reliance, UK Conformity Assessed (UKCA) marking and in ...
Early diagnosis through the use of in vitro diagnostics (IVDs) plays a critical role in patient outcomes and in supporting the healthcare system as a whole. IVDs are defined in the new EU IVDR ...
WASHINGTON, Oct. 31, 2022 /PRNewswire/ -- MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory ...
New Delhi [India], October 24: Indian IVD manufacturers face growing regulatory hurdles under the EU IVDR. I3CGLOBAL provides strategic CE Marking support to small, medium, and large-scale ...
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