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  • Feature ArticlesFeature Articles

    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 ...
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    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...
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    OTC monograph reform is now law: What’s next?

    This article discusses the impact of over-the-counter (OTC) monograph reform, part of the recently passed Coronavirus Aid, Relief and Economic Security (CARES) Act . Regulators and public health stakeholders have been championing OTC monograph reform for more than five years. Then, in what seems like a blink of any eye, it is now law, passed by Congress and signed by the President on 27 March 2020 as part of the CARES Act for pandemic relief. The new law reflects the...
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    Regulatory operations, ethics and the global landscape

    Feature articles throughout March covered a variety of topics by leading regulatory experts, including underlying root causes of serious and continuing noncompliance and how professionalism, integrity and ethics can enhance communication between regulatory and cross-functional teams. Other key topics included the progression of regulatory intelligence and strategy to foster the evolving landscape, how the role of regulatory operations professionals is evolving and understa...
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    Responding to serious or persistent noncompliance

    This article identifies some root causes of serious and continuing noncompliance and describes the Professionalism and Integrity (PI) in Research Program, a first-of-its-kind nonprofit educational program developed to remediate noncompliance. By describing the evidence-based goals and curricular strategies developed by one program, this article offers regulatory professionals not only a training referral option, but a variety of issues to consider when developing action pl...
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    Key concepts to enhance regulatory communication and ethics in the current environment

    This article discusses the current regulatory environment and presents several ideas for enhancing communication among regulatory and cross-functional teams. The author presents three key concepts for achieving this, including the flow of knowledge and information, senior regulatory presence with minimal hierarchy and applying appropriate regulatory strategies for achieving timely approvals and cites RAPS core values for maintaining regulatory ethics.   Introduction ...
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    Improving communication with health authorities throughout the eCTD submission process

    This article discusses the benefits of understanding the role of regulatory operations and facilitating proper internal team communication with regulatory affairs to support efficient and clear communication with health authorities through the eCTD submission process. The author highlights steps and procedures to improve both understanding and carrying out the submissions process. Topics include PDF processing, metadata, hyperlinks quality control and more.   Introduct...
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    Apostille and consular legalization: Critically important, often overlooked

    This article discusses document authentication processes often required when companies export goods internationally with a focus on corporate documents. The author provides case studies to help clarify procedures.   Document Authentication 101   In the US, companies are required to have specific documents authenticated before they are able sell products in international markets. Depending on the destination country for the product(s), the authentication process is ...
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    Preparing for High-Stakes Regulatory Meetings in the US and Europe

    This article provides regulatory professionals with an understanding of the specifics of FDA Advisory Committee (ADCOM) and Committee for Medicinal Products for Human Use (CHMP) Oral Explanation (OE) meetings. The authors outline key guiding principles to help regulatory teams more effectively structure their preparation timelines, bring focus to their pre-meeting work and ensure they perform well on meeting day.   The article is based on a presentation by the authors ...