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The European Medicines Agency issued a draft guideline on quality requirements for combination devices, opening the guidance up to a three-month public consultation. Read More
After months of criticism of the European Commission for the slow release of guidance on the EU’s new medical device regulations, the Commission released a flurry of documents on the Eudamed data exchange. Read More
At the recent International Medical Device Regulators Forum (IMDRF) meeting in Moscow, Japanese and South Korean regulators said they plan to introduce mechanisms to allow for rapid access to needed devices and in vitro diagnostics. Read More
CDRH released final guidance for device sponsors on requesting feedback or meetings with agency officials ahead of investigational device exemption (IDE) or other marketing submissions under the Q-Submission program. Read More
Harmonized standards are key for applying Europe’s new medical device and in vitro diagnostics regulations, but the European Commission’s latest draft of the standards to be considered is filled with technical errors that would result in a lack of standardization, MedTech Europe said. Read More
The European Commission’s Medical Device Coordination Group (MDCG) released a Q&A on requirements for notified bodies (NBs) under the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR). Read More
The International Medical Device Regulators Forum (IMDRF) has released a draft guidance laying out regulatory pathways for personalized medical devices. Read More
The FDA issued final guidance on the information devicemakers should include in test report summaries, test protocols and complete test reports for non-clinical bench performance testing for premarket submissions. Read More
Health Canada is increasing fees for device sponsors and will peg ongoing increases to inflation, the agency said in a final report on the planned changes. Read More
The FDA issued an alert over a recall of Beckman Coulter DxH 800, DxH 600 and DxH 900 blood analyzers, updating an urgent medical device correction letter the company issued following complaints of inaccurate blood platelet counts. Read More
The European Commission released new details on what datasets devicemakers should include in the Eudamed database for unique device identifiers under the new Medical Device Regulation and In Vitro Diagnostic Regulation. Read More
Health Canada issued final guidance for devicemakers on supporting evidence required for submitting applications for 3D-printed implantable devices. Read More