Medical Innovation Exchange

medical device regulation

FDA Outlines its Approach to Artificial Intelligence Regulation

FDA Outlines its Approach to Artificial Intelligence Regulation     U.S. regulation of artificial intelligence (AI) in medical devices will involve cooperative work among multiple departments within the FDA. On March 15, the FDA released “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” which outlines how the agency’s medical product …

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MHRA Releases Roadmap of Future UK Medical Device Regulation

MHRA Releases Roadmap of Future UK Medical Device Regulation     On January 9, The UK Medicines and Healthcare products Regulatory Agency (MHRA) announced its plan for medical device regulation. The ‘roadmap’ for new regulations sets out a route to deliver new regulations via a series of new Statutory Instruments (SIs). The agency will put priority …

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Bringing your Medical Device to the UK: What You Need to Know about UKRP

Bringing your Medical Device to the UK: What You Need to Know about UKRP     When it comes to medical device regulations, it is a time of transition for a number of countries. Both the EU and the UK are in the process of making significant changes to their regulations: Europe is in fact transitioning …

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Beyond EU MDR: Unleashing Opportunities to Innovate and Ensure Patient Safety

Beyond EU MDR: Unleashing Opportunities to Innovate and Ensure Patient Safety     A harmonious blend of innovation and patient safety is paramount in today’s ever-evolving medical device regulatory landscape. Furthermore, sustainability of massive regulatory data, updates to the evolving regulations, adherence to country-specific requirements, and adoption of an intelligent yet cost-effective approach to reducing overhead …

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Clock Starts for New EU MDR Transition Dates

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 …

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New Resource Sheds Light on FDA CDRH Regulatory Focus

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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Developing an Effective and Sustainable Regulatory Strategy for Today’s Global Market

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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FDA Issues Draft Guidances on Human Factors and VMSR for Medical Devices

FDA Issues Draft Guidances on Human Factors and VMSR for Medical Devices     The FDA has issued two new draft guidances: Content of Human Factors Information in Medical Device Marketing Submissions and Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. The “Content of Human Factors Information in Device Marketing Submissions” draft guidance offers a risk-based …

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