QA/RA Consulting, Auditing & Training
EUDAMED Is Live – and It’s Mandatory For years, EUDAMED was the regulatory equivalent of “coming soon.” Now that it’s here, it is operational for medical device and IVD companies that are marketing products in the EU and, for many companies, it is no longer a future project. It is now a part of a […]
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From Assays to MOSAIC Platforms: The Next Operating Model for Precision Medicine Introduction Across pharmaceutical and in vitro diagnostics (IVD) organizations, the same questions continue to be asked related to precision medicine: When does a biomarker assay transition from an exploratory research tool into a development-critical decision tool? Can investigational assays, laboratory-developed tests (LDTs), or […]
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Navigating the Final Countdown: Key Deadlines and Compliance Requirements for IVDR Transition Understanding the EU IVDR Compliance Deadlines The EU In Vitro Diagnostic Regulation (IVDR) (EU 2017/746), which went into effect on May 26, ├é┬á2022, replaces the In Vitro Diagnostic Directive 98/79/EC (IVDD). It introduces stricter requirements, including new risk classifications, increased clinical evidence requirements, […]
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Which EU Notified Bodies Have Been ├óΓé¼┼ôDesignated├óΓé¼┬¥ Under the MDR 2017/745 and IVDR 2017/746? Shown below is a list of European Notified Bodies that have been designated under the EU MDR or IVDR. As Notified Bodies are officially designated, we will add them here. Help us keep this information up to date.├é┬áEmail us├é┬áwith corrections or […]
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MDCG 2022-6: Making Changes to Legacy Devices Without Triggering EU IVDR Compliance In May 2022, the Medical Device Coordination Group (MDCG) issued├é┬áMDCG 2022-6, which outlines allowable changes under the IVDR to manufacturers holding valid IVDD device certificates. This guidance document clarifies Article 110(3) of the IVDR, which is reproduced below: Below are some of the […]
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The New IVDR Compliance Deadline Extension Explained The European Commission after catching heat from Notified Bodies and industry players alike finally came to the conclusion that perhaps forcing a May 2022 compliance deadline on thousands of ill-prepared├é┬áin vitro├é┬ádiagnostic (IVD) manufacturers was not going to end well. As such, the recent decision by the commission to […]
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