Sean Smith

The Real Impact of IVDR on Clinical Evidence Requirements

By Sean Smith

For many manufacturers of IVD devices now on the European market, meeting the evidence required of the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) will require tremendous work….

For many manufacturers of IVD devices now on the European market, meeting the evidence required of the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) will require tremendous work….

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Veranex logo

Veranex Acquires Medidee

By MedTech Intelligence Staff

…clinical development and quality assurance services for medtech companies, including an improved ability to navigate EU-MDR/IVDR challenges thanks to Medidee’s experience in the European regulatory space. “Our acquisition of Medidee…

…clinical development and quality assurance services for medtech companies, including an improved ability to navigate EU-MDR/IVDR challenges thanks to Medidee’s experience in the European regulatory space. “Our acquisition of Medidee…

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Peter O‘Blenis, Evidence Partners

Streamlining the Literature Review Process

…to evidence-based research in the context of EU MDR compliance and, more specifically for clinical evaluation reports (CER) and performance evaluation reports (PER)? O’Blenis: Literature reviews have always been the…

…to evidence-based research in the context of EU MDR compliance and, more specifically for clinical evaluation reports (CER) and performance evaluation reports (PER)? O’Blenis: Literature reviews have always been the…

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Laura Johnson

Device Labeling: Best Practices

By MedTech Intelligence Staff

Europe, as a brand owner they could use the address of the U.S. facility. One of the major changes with EU MDR was that the address needs to reflect where…

Europe, as a brand owner they could use the address of the U.S. facility. One of the major changes with EU MDR was that the address needs to reflect where…

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Jaishankar Kutty

The Same, But Not Identical: Demonstrating Biological Equivalence Under MDR

By Jaishankar Kutty, Ph.D.

…needed to achieve compliance with the EU Medical Device Regulation (MDR), leveraging equivalence may be a favorable route. In principle, manufacturers can assess risk by comparing similarities and differences between…

…needed to achieve compliance with the EU Medical Device Regulation (MDR), leveraging equivalence may be a favorable route. In principle, manufacturers can assess risk by comparing similarities and differences between…

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SOTA

State-of-the-Art: Unpacking MDR’s Evolving Requirements

By Elisabeth Liljensten, Lina Burman, Mark Cabonce, M.S., DABT, Monica Grekula

Per EU MDR regulations, any medical device on the market must be considered “state-of-the-art.” However, the term is not explicitly defined. Exploring MDR verbiage around standards harmonization, risk management and…

Per EU MDR regulations, any medical device on the market must be considered “state-of-the-art.” However, the term is not explicitly defined. Exploring MDR verbiage around standards harmonization, risk management and…

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Drexler and Racine

Drexler and Racine Join HUMA.AI Advisory Board

By MedTech Intelligence Staff

Huma.AI, a developer of machine learning technology solutions for the life sciences, has appointed Karen Drexler to its board of directors and Jean-Olivier ‘J-O’ Racine to its strategic advisory board….

Huma.AI, a developer of machine learning technology solutions for the life sciences, has appointed Karen Drexler to its board of directors and Jean-Olivier ‘J-O’ Racine to its strategic advisory board….

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European Union Flag

European Commission Adopts Common Specifications for High-Risk Diagnostics

By MedTech Intelligence Staff

On July 4, The European Commission adopted common specifications for several types of high-risk diagnostics. The specifications set uniform and rigorous benchmarks for tests across the EU, with the goal…

On July 4, The European Commission adopted common specifications for several types of high-risk diagnostics. The specifications set uniform and rigorous benchmarks for tests across the EU, with the goal…

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Evidence Partners and Akra Team Join Forces To Help Medical Device Companies Accelerate Completion of EU MDR and IVDR Submissions

By MedTech Intelligence Staff

…that make it easier and faster for medical device companies to complete EU MDR and IVDR notified body submissions. The partnership brings together DistillerSR and the Akra Team’s strategic regulatory…

…that make it easier and faster for medical device companies to complete EU MDR and IVDR notified body submissions. The partnership brings together DistillerSR and the Akra Team’s strategic regulatory…

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