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The International Medical Device Regulators Forum (IMDRF) has released a draft guidance laying out regulatory pathways for personalized medical devices.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
The guideline details information sponsors need to include in their initial marketing authorization applications and during their products’ lifecycle. Read More
“This situation will lead to a lack of alignment between notified bodies with respect to the conformity assessment procedure,” MedTech Europe says. Read More