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  • Feature ArticlesFeature Articles

    Outsourcing in regulatory operations

    This case study explains Project BRIDGE and its vision to centralize process and services, such as dossier planning, compilation and publishing, submission, tracking and archiving to efficiently ensure compliance, increase transparency and maintain or improve quality of submissions to global health authorities. Introduction The author began employment at Boehringer Ingelheim, a large global pharmaceutical company with headquarters in Germany in October 2014. At that ti...
  • Feature ArticlesFeature Articles

    EU device regulations, COVID-19 response and global regulatory strategy

    Feature articles during April focused predominantly on the new European Medical Devices Regulation ( EU MDR ), In Vitro Diagnostic Medical Devices Regulation ( EU IVDR ) and the COVID-19 pandemic, with a number of regulatory experts examining the impact of pandemic-related delays on the progression of the European regulations. Also included were articles on the European Database on Medical Devices (Eudamed), the Mutual Recognition Agreement (MRA) between Switzerland an...
  • Feature ArticlesFeature Articles

    New claims under EU MDR and EU IVDR

    This article discusses medical device promotional and advertising product claims under Article 7 of the European Union’s new Medical Devices Regulation ( EU MDR) and In Vitro Diagnostic Medical Devices Regulation (EU IVDR) and examines how and when product claims are misleading or false as defined under the regulations. Introduction    Article 7 of the EU MD R 1 and EU IVDR 2 provide new claims regulations for medical devices. All of the requirements relate ...
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    Preparing for EU MDR translation

    This article discusses what medical device manufacturers need to know about product information language translation as required by European Medical Devices Regulation ( EU MDR ). The author addresses how companies can better meet the regulation’s language component requirements and offers suggestions ranging from being aware of who the information reading audience is and hiring professional translators.   Introduction   The complex regulatory requirements for EU ...
  • Feature ArticlesFeature Articles

    Communication During a Pandemic

    This article offers best practices for company communication during a pandemic, such as the current COVID-19 global emergency. The author emphasizes the need to make company communications responsible and thoughtful, not only in these challenging times, but always. Discussed are best practices for communication through many mediums, such as telephone calls, email and social media and doing so in such a way that the message is not misinterpreted, misleading, sent to the wro...
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    Optimizing remote internal quality audits

    This article provides tips and techniques for effective, risk-based remote internal quality auditing methods in a good manufacturing process (GMP) quality management system. The author covers the circumstance in which a “virtual” audit may be necessary or desirable as opposed to an on-site audit and discusses potential challenges when auditing off-site and how to overcome them. She emphasizes good communication skills, discusses the characteristics of various internal audi...
  • Feature ArticlesFeature Articles

    EU IVDR changes regulatory landscape

    This article discusses new requirements for technical documentation, periodic safety reports, notified body changes, postmarket surveillance and vigilance, labeling and product traceability under the European Union’s new In Vitro Diagnostic Regulations (EU IVDR).   Introduction   Many regulatory changes are scheduled to come into effect in May 2022 as part of the new EU IVDR (2017/746.) 1 However, it likely that EU IVDR will come into effect a year later t...
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    EU MDR impacts MRA Switzerland–EU

    This article discusses the potential impact of not renewing the bilateral Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) regarding medical devices prior to the proposed new EU MDR implementation date of May 2021. The author explores a range of negative impacts affecting the medical device industry in Europe and patients if the MRA is not renegotiated before that deadline. He reviews the historical long-standing relationship between Swi...
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    EU MDR’s proposed delay and ISO 10993-18 compliance

    This article discusses the latest update to ISO 10993-18 released in January 2020. The author identifies changes implemented by this update and explains how they intensify the identification standard for medical devices and create new challenges for those companies working to certify devices under the European Medical Devices Regulation ( EU MDR). 1 The author suggests that while regulatory professionals must understand this standard to ensure their submissions are ful...
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    COVID-19 impacts EU MDR’s proposed delay

    This article discusses implications for the proposed May 2021 deadline for EU MDR caused by the impact of the COVID-19 pandemic. While saying the proposed one-year extension may give manufacturers additional time to prepare, the author reviews what must be done for compliance, despite the new EU MDR deadline. In reviewing those compliance steps, she explains why many medical devices will likely be dropped from the market as manufacturers are forced to make a choice to ...
  • Feature ArticlesFeature Articles

    Preparing for virtual regulatory meetings

    This article discusses how sponsors can prepare for their meetings with regulators in light of the recent FDA and EMA announcements that Advisory Committee meetings and Oral Explanations—as well as other “essential” regulatory meetings—will be conducted virtually. While this article specifies Advisory Committee meetings and Oral Explanations, the need for preparedness and tools described also applies to any virtual meetings that are held with health authorities.   Intro...
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    Eudamed’s delay and its impact on clinical investigations under the EU MDR

    This article reviews possible ramifications caused by the delay in launching the European Union’s new electronic database, the European Database on Medical Devices (Eudamed).The author discusses potential issues when clinical investigation data is not transparent or accessible. Until Eudamed is available, posting study results on other databases is recommended so manufacturers can meet requirements for clinical investigation transparency and disclosure while sharing clinic...