GxP Lifeline

Showing items tagged as Medical Device Regulation (MDR)

  • 2021-bl-standards-harmonization-and-eu-mdr_132x132

    5 Tips to Manage the EU MDR Harmonized Standards

    With the roll out of the EU’s Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR), an increasing number of harmonized standards are out of date. This post addresses the current status of harmonized standards under MDR/IVDR and provides tips for dealing with the challenges of meeting compliance with the new regulations.

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  • 2021-bl-med-device-trends_132x132

    Digitization in Medical Device Manufacturing: 4 Priorities

    Though most manufacturers may recognize the benefits of digital transformation, many don’t see the roadmap. But there is a realistic path forward that helps mitigate or minimize many real barriers. The key is to make small changes in areas where you will see the biggest impact.

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  • 2020-bl-managing-compliance-costs_132x132

    EU’s MDR Calls for Summary of Safety and Clinical Performance

    With the fast-approaching Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), medical device manufacturers will be seeing more documentation requirements. One of the new documents is a summary of safety and clinical performance (SSCP). This is one of the annual reports manufacturers must provide throughout the life cycle of a device in order to remain compliant to sell products in the EU.

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  • 2020-bl-thumb-qserveeu-mdr-update

    EU's MDR Extended: Where Do Medical Device Manufacturers Stand?

    The much-anticipated one-year delay of the European Union’s Medical Device Regulation (MDR) finally dropped earlier this month. Gert Bos, Executive Director and Partner of the Qserve Group, breaks down what this means for device manufacturers and for their preparations to recertify under the new regulation through a designated Notified Body.

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  • 2020-bl-thumb-importance-of-intended-purpose

    The Importance of Intended Purpose and State of the Art in Implementing EU’s IVDR

    The European Union’s In Vitro Device Regulation (IVDR) is replacing the In Vitro Device Directive (IVDD) on May 20, 2022, and there’s not a moment to spare in preparing for the new regulation. An in vitro diagnostic (IVD) expert with QServe lays out the most important requirements of IVDR that IVD manufacturers will need to begin planning for to recertify their devices.

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  • 2019-bl-thumb-brandwood-transition-from-mdd-to-mdr

    Q&A: Device Manufacturers’ FAQs on the EU’s Medical Device Regulation (MDR)

    Medical device manufacturers globally are grappling to recertify their devices against the European Union’s new Medical Device Regulation (MDR), which takes affect May 26, 2020. To help manufacturers make sense of the MDR, a Q&A was conducted with two medtech subject matter experts who tackle some of the most commonly asked questions about the MDR and how to approach it.

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  • 2019-bl-thumb-mdr-and-notified-bodies

    Uncertainty Regarding EU MDR Underscores Importance of Certification Preparation

    Europe’s new regulation for medical devices, the Medical Device Regulation (MDR) takes effect May 26, 2019. Due to confusion regarding the regulation’s requirements and a lack of Notified Bodies to recertify medical devices under the new law, greater clarity is needed. Learn the latest on the developing situation and what med dev companies can do to prepare to recertify their devices.

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  • 2019-bl-thumb-brandwood-transition-from-mdd-to-mdr

    6 Tips for a Successful Transition to the EU MDR

    Considering the uncertainties surrounding the European Union’s implementation of the Medical Device Regulation (MDR) beginning in May 2020, many device makers are wondering how to proceed toward certification. Despite a lack of official guidance, there are several steps medical device manufacturers can do to prepare themselves to certify and implement Europe’s new regulations.

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  • 2019-bl-thumb-new-european-mdr-regulation-how-will-affect-software

    EU MDR: How Will Europe’s New Device Regulation Affect Software?

    The European Union’s Medical Device Regulation (MDR) will replace the older Medical Device Directive beginning in May 2020. While this is presenting new regulatory challenges to device makers, medtech companies also need to consider how MDR will impact their production data and software systems. Companies that are well-prepared and have a robust quality management system will be best positioned to implement the new regulation.

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  • 2019-bl-thumb-brandwood-biomedical-1

    Surviving the Perfect Storm – International Harmonization for Medtech

    The evolution of regulatory changes in the European Union with it’s Medical Device Regulation (MDR), the U.K.’s Brexit, and changes in Canada and elsewhere are creating a global ripple effect in the medical device industry. These hurdles may cause uncertainty for device makers, but through careful preparation and planning, medtech companies adjust their strategies and approaches during this transitionary period.

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  • 2019-bl-build-an-effective-global-regulatory-strategy-page-image

    Building an Effective Global Regulatory Strategy for Medical Devices

    As new technologies evolve, the device requirements for medical device companies in various global markets has become more complex and nuanced. To be successful in key markets around the world, device makers need to study these regulatory environments and develop a strategy to more seamlessly and efficiently acquire regulatory approvals.

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  • 2019-bl-thumb-asia-pacific-regulatory-changes-to-med-dev

    Top Regulatory Trends Affecting Med Dev in Asia-Pacific Moving into 2019

    Despite a virtual kaleidoscope of continual regulatory fluctuations, 2019 presents some potentially very attractive market expansion opportunities in Asia-Pacific, including China, India, Australia and Japan. Get a comprehensive overview of device markets and their promising potential.

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  • 2019-bl-thumb-seeking-simultaneous-regulatory-approval

    Simultaneous US/EU Regulatory Approval: How Timing Could Be a Factor

    Regulated companies seek every opportunity to get products on the global market faster, even pursuing simultaneous regulatory approval in two of the largest global markets – the United States (U.S.) and the European Union (EU). However, governing entities in both regions are embarking on changes that could disrupt this strategy.

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  • 2018-bl-thumb-regulatory-barriers-for-biotech-medtech-startups-europe

    2019 Med Device Trends to Watch For: Regulatory Changes

    For the medtech industry, 2019 is going to be marked by a slew of regulatory changes, beginning with Canada’s requirement of Medical Device Single Audit Program (MDSAP), which took effect on Jan. 1.

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  • 2018-bl-thumb-medtech-europe-urges-european-commission

    How Approaching MDR/IVDR Deadlines Are Impacting Med Device Industry

    The countdown to the Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR) deadlines is underway. However, transition issues are creating a logistical logjam for both the medical device industry and the European Commission (EC), which is impacting the med device industry. MedTech Europe still wants the EC to stop the clock.

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  • 2018-bl-thumb-clinical-trends-med-device

    Noteworthy Clinical Trends in Med Device to Watch in 2018

    Radical, whirlwind change is a core feature of the medical device industry. A clinical/regulatory expert provides insight into the clinical developments currently shaking up the device world and explains how device companies can adapt and thrive in a burgeoning industry that seems to reinvent itself daily.

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  • 2020-bl-mc-insights-01_132x132

    Is Supplier Quality a Fallacy? Implement Risk-Based Control in Design

    Medical device manufacturers must rely on more than their buyers or procurement group to provide supply quality. In order to be successful, companies must implement risk-based design controls in order to minimize risk and maximize benefits to their supply quality process.

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  • 2018-bl-thumb-tga-process-conformity-assess

    TGA Process for Conformity Assessment in Australia

    If you’re considering the Australian market for your medical device product and don’t have CE marking, the conformity assessment is an ever-increasing opportunity to enter the market. Furthermore, with the ever-changing landscape in Europe, many would suggest that Australia's Therapeutic Good Administration (TGA) is a well-established and understood pathway, whereas the European market is becoming somewhat more challenging and less understood.

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  • 2020-bl-compliance_132x132

    Top 5 Trends That Will Shape the Medical Device Industry in 2018

    At the beginning of each year, it’s intriguing to look into a crystal ball to get a glimpse of what the upcoming year will look like. Given how fast technology evolves, if you so much as blink you could miss out on critical insight regarding some new trends.

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  • smart-document-contract-132

    New European Med Device Regulation: 2020 Looms Large for Medtech Firms

    In 2020, the United States will hold a presidential election. Tokyo will host the Summer Olympics. For the medtech industry, the European Union’s Medical Device Regulation (MDR) will take effect. Politicians and athletes have been gearing up for 2020 and so should medical device firms.

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