Medical Innovation Exchange

EU MDR

EU MDR: MDCG Proposes Extended Timeline for Legacy Device Compliance

EU MDR: MDCG Proposes Extended Timeline for Legacy Device Compliance     Legacy devices may have more time to come into compliance with EU Medical Device Regulations (MDR). On December 9, the European Commission’s Medical Device Coordination Group (MDCG) issued the “MDCG Position Paper on the application of Article 97 MDR to legacy devices for which …

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Ask the Expert: EU MDR as a Trigger for Innovation

Ask the Expert: EU MDR as a Trigger for Innovation     Much of what has been written about the EU MDR emphasizes the increased regulatory burden that it puts on medical device companies. Giotto Compliance looked at the bright side of the new regulations and viewed EU MDR requirements as a catalyst to drive innovation …

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Swiss National Council Votes To Accept FDA Approved Medical Devices

Swiss National Council Votes To Accept FDA Approved Medical Devices     On November 28, the Swiss Parliament National Council voted to adapt its national laws, allowing Switzerland to accept medical devices with FDA approval. Since 2001, healthcare providers and patients in Switzerland have only had access to medical devices with an EU certificate. Swiss MedTech, …

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Life Sciences Labeling for Patient Safety

Life Sciences Labeling for Patient Safety     Labeling regulations from the FDA and European Union (EU) are continuously changing to protect public health and improve patient safety. The Drug Supply Chain Security Act (DSCSA) enhances FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful. These …

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Veranex Acquires Medidee

Veranex Acquires Medidee     Veranex, a global, tech-enabled service provider dedicated to the medical technology industry, has acquired MedTech consultancy Medidee, headquartered in Lausanne, Switzerland. The acquisition will expand and strengthen Veranex’s regulatory affairs, clinical development and quality assurance services for medtech companies, including an improved ability to navigate EU-MDR/IVDR challenges thanks to Medidee’s experience …

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Device Labeling: Best Practices

Device Labeling: Best Practices     EU MDR required companies to make significant changes to their medical device labels, highlighting the need for a well-coordinated and agile device labeling process. We spoke with Laura Johnson, director of sales with Loftware, an enterprise labeling and artwork management provider, to discuss common pain points in label development and …

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

The Same, But Not Identical: Demonstrating Biological Equivalence Under MDR     Equivalence strategies can be used to efficiently demonstrate the safety of a medical device, limiting the need for new studies and testing. Given the level of investment that may be needed to achieve compliance with the EU Medical Device Regulation (MDR), leveraging equivalence may …

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

State-of-the-Art: Unpacking MDR’s Evolving Requirements     The Oxford Dictionary defines “state-of-the-art” as something that belongs or relates to the most recent stage of technological development. It is something that incorporates the newest technology, ideas and features. In short, state-of-the-art means the most advanced, sophisticated, innovative version of a thing. The European Union’s Medical Device Regulation …

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