Medical Innovation Exchange

EU MDR

Enhancing Post-Market Surveillance: Strengthening Medical Device Regulation in the UK

Enhancing Post-Market Surveillance: Strengthening Medical Device Regulation in the UK     The UK’s medical device and in-vitro diagnostic device regulation is undergoing significant changes to enhance post-market surveillance (PMS) requirements. The MHRA (Medicines and Healthcare Products Regulatory Agency) conducted a consultation, which received responses supporting the need for more transparent and risk-proportionate PMS requirements. Consequently, the …

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Preparing for EU MDR Post Market Reporting

Preparing for EU MDR Post Market Reporting     EU MDR continues to pose challenges as companies prepare to recertify devices and bring new technologies to the European market. One of the big changes in the regulatory framework of EU MDR versus the current medical device directive (MDD) is the focus on post market surveillance (PMS) …

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EU MDR: Ensuring Labeling Compliance

EU MDR: Ensuring Labeling Compliance      In July 2023, the European Parliament granted an extension to the new European Union Medical Device Regulation (EU MDR). This extension acknowledges the challenges that have arisen due to slow market readiness and lack of notified bodies, and  grants companies additional flexibility to meet the demand for safe, innovative …

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EU MDR Annex XVI Introduces New Burdens for Products Without an Intended Medical Purpose

EU MDR Annex XVI Introduces New Burdens for Products Without an Intended Medical Purpose     Adopted in 2017, the EU Medical Device Regulation (MDR) brought a host of changes. In its Annex XVI, for example, the regulation expands its scope to take in new product groups referred to as “products without an intended medical purpose”—in …

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The MDR Deadline Extension: Use the Time Wisely

The MDR Deadline Extension: Use the Time Wisely     On March 15, 2023, the European Parliament amended the original Medical Device Regulation (MDR) to lengthen the compliance period for certain medical devices and in vitro diagnostic devices. The move provides device manufacturers with additional time to prepare their products for market and offers a buffer …

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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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What’s Happening in the UK and Switzerland

What’s Happening in the UK and Switzerland     The implementation and extensions of EU MDR/IVDR have caused significant stress on regulatory departments. These challenges have been compounded by Brexit and the UK’s announcement that it would not adopt EU MDR/IVDR and the Swiss National Council’s vote to allow FDA-approved devices into the Swiss market. During …

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Implementing MedTech Price Increases in Times of Inflation and EU MDR

Implementing MedTech Price Increases in Times of Inflation and EU MDR     Steadily high inflation is putting pressure on medical technology companies around the world; costs for raw materials, transportation, warehousing, wages, and more continue to rise. Eighty-seven percent of medical technology companies are feeling these pressures very keenly.[1] Additionally, in Europe, the Medical Device …

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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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