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Clock Starts for New EU MDR Transition Dates An extension to the EU MDR transition period, approved by the European Council on March 7, is now in force following its publication in the Official Journal of the European Union on March 20. Producers of medical devices will now have until December 31, 2027, for …
New Resource Sheds Light on FDA CDRH Regulatory Focus Device developers seeking insight into the current thinking of the FDA Center for Devices and Radiological Health as well as those pursuing a career in regulatory affairs have a new resource available. Elijah Wreh, Professor of Regulatory Science and Senior Manager Regulatory Affairs at Boston …
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E-labeling: The Road to Reduced Medical Device Packaging Material In the consumer world, it’s now common practice to access product information online. For detailed instructions or information about manufacturing practices, safety advice and so on, users can scan a QR code or go to a web address, which takes them to the latest details, …
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Increasing Momentum in Medical Device Security In 2021, an employee at Ireland’s public health and social services system—the Irish Health Services Executive (HSE)—opened a spreadsheet that was sent by email. The file contained malware. After two months of free access to the network, the attackers released ransomware into the system. As the BBC reports, …
Developing an Effective and Sustainable Regulatory Strategy for Today’s Global Market Global regulatory demands for medical devices are increasing substantially, and regulatory teams are faced with the pressure of increased workloads and the need for more resources. To help regulatory professionals identify strategies and best practices in developing an effective and sustainable regulatory strategy …
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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 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 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 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 …
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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