Medical Innovation Exchange

Quality/Regulatory

Tackling Go-To-Market Challenges

Tackling Go-To-Market Challenges     The medical device industry is amid an era of unprecedented regulatory complexity. Every 22 minutes, a new or updated regulatory requirement is issued somewhere in the world. All told, this amounts to 22,000 new or updated regulations every year, and it has led to a 150% increase in regulatory mandates over …

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FDA Seeks Input on Advancing Use of Real-World Data and Evidence

FDA Seeks Input on Advancing Use of Real-World Data and Evidence     The FDA is seeking input from stakeholders on how it should use user fee funding for engaging with external organizations, other than the National Evaluation System for Health Technology (NEST), to support premarket Real-World Evidence. Under the fifth reauthorization of the Medical Device …

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FDA To Host Webinar on Electromagnetic Compatibility of In Vitro Diagnostic Devices

FDA To Host Webinar on Electromagnetic Compatibility of In Vitro Diagnostic Devices     The FDA is hosting a webinar on February 2 from 1:00-2:00pm ET for interested stakeholders to discuss the final guidance Electromagnetic Compatibility (EMC) of Medical Devices and its applicability to in vitro diagnostic (IVD) devices. The FDA announced that during this webinar it …

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European Commission Proposes Extended Timeline for EU MDR/IVDR Compliance  

European Commission Proposes Extended Timeline for EU MDR/IVDR Compliance       On January 6, the European Commission adopted a proposal to give more time to certify medical devices under EU MDR to mitigate the risk of shortages. The proposal now needs to be adopted by the European Parliament and the Council. The proposal introduces a …

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Risk Management Is More Than a Spreadsheet

Risk Management Is More Than a Spreadsheet     In a previous article, we discussed several causes that lead to product malfunctions and how to mitigate them. In this article, we will look at how a change from a document-driven risk management approach to a data-driven risk management approach can help mitigate product failure. Mitigating risk …

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MedTech Intelligence Announces 2023 Conference Series

MedTech Intelligence Announces 2023 Conference Series     Since 2010, MedTech Intelligence has produced valuable in-person conferences, and after three years of webinars, we are thrilled to bring back our in-person conference series to Washington, DC. The conference location brings in many high-level speakers from industry and FDA. Attendees can take advantage of networking opportunities, presentations …

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FDA Highlights Exemptions for Real World Data-identified AEs

FDA Highlights Exemptions for Real World Data-identified AEs     On December 20, the FDA updated its Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices web page to remind manufacturers that it has granted several exemptions to its Medical Device Reporting (MDR) requirements related to events identified in certain real-world data (RWD) …

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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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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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Contamination Control: Practical Steps to Compliance with EU GMP Annex 1

Contamination Control: Practical Steps to Compliance with EU GMP Annex 1     In August 2022, revised EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products were issued, starting the clock for compliance. All but one of the new provisions must be fulfilled by August 2023. The updated requirements, designed to protect …

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