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    Contingency Plans for MDR and IVDR Implementation for a no Deal Brexit

    This article discusses implementation of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) regarding the potential exit (called Brexit) of the United Kingdom (UK) from the European Union (EU). The author suggests the fate of regulations will be not without consequence should the UK and the remaining members of the EU find they are unable to negotiate how medical devices will be regulated, sold and moved between the UK and t...
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    Impact of Regulation 2017/745 (MDR) on the Relationship Between Medical Device Manufacturers and Their Suppliers and Subcontractors

    This article highlights the imminent regulatory challenges posed by the European Union’s (EU) Medical Devices Regulation (MDR) 2017/745. The authors propose a “balanced approach” for maintaining compliant supplier quality agreements for the new regulatory landscape. The authors assess the impact of EU MDR, cover the implications for quality agreements between medical device manufacturers and suppliers and discuss strategies for legal manufacturers achieving compliance with...
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    Breaking Down UDI Questions

    This article answers questions and clears up ambiguities related to the Unique Device Identification (UDI) system developed for medical devices related to US and European Union (EU) regulations. The author presents an in-depth discussion of terms including base package, unit of use, packaging levels, UDI databases, accessories and spare parts, UDI ownership and scanning versus verifying. She also looks at UDI development outside of the US and EU.   Introduction   ...
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    Challenges in Clinical Evaluation for the EU Versus China

    This article illustrates how to write a Clinical Evaluation Report (CER) based on China’s National Medical Products Administration (NMPA) guidance and how to convert and submit existing EU CER requirements for NMPA, formerly the China Food and Drug Administration (CFDA). The authors compare and contrast the process of converting an MDR compliant CER for submission in China by demonstrating the differences in requirements, outlining specific requirements for China and p...
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    Postmarket Surveillance and Postmarket Clinical Follow-up

    This article discusses the scope of postmarket surveillance activities within the European Union (EU) as set out in Medical Devices Regulation (MDR 2017/745) . 1 The author explains the difference between postmarket surveillance (PMS) versus market surveillance regarding regulatory compliance, discusses PMS plan minimum technical content, persons responsible for regulatory compliance, PMS reporting, types of reports, postmarket clinical follow-up and transparency, accoun...
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    The Essential IVDR and the Challenges it Presents

    This article discusses key elements of the In Vitro Diagnostic Regulation (IVDR) and the challenges it presents to manufacturers. The author covers device classification changes, oversight, clinical evidence and performance evaluation, and postmarket vigilance. She cautions about the effects of notified body reductions and the consequences. She concludes by warning that significant changes may impede market launch for some products.   Introduction   It is essential...
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    Incorporating Clinical Evaluation Requirements Into the Design and Development Process Under MDR

    Focusing on the new European Medical Devices Regulation 2017/745 (MDR), this article reviews a number of regulatory changes and covers several questions important to manufacturers regarding clinical evidence, clinical data, clinical evaluation, clinical safety, clinical performance, clinical outcomes and how they may fit together under new MDR requirements. The author speculates on the impact MDR might have on the design and development process while focusing on the incorp...
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    Implementation of IVDR and MDR Into National Legislation

    This article discusses current revisions to the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) in the European Union (EU). The authors use an example from Germany’s experience and efforts to examine revisions from an implementation perspective. The impact of this new regulatory environment and associated challenges for medical device and in vitro diagnostic device manufacturers are discussed as well as hurdles and “bottlenecks” that could m...
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    Changing Role of Regulatory Professionals, Career Development and Global Regulations

    Feature articles in August covered the changing role of regulatory professionals including critical thinking and leadership skills, professional development strategies, the importance of obtaining professional qualifications and techniques for transitioning roles in a contract research organization. Other articles covered eCTD submission management, FDA’s TRG Rapid Inquiry Program, an overview of administrative law and considerations for implementation of a companion diagn...
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    Considerations for Development and Implementation of a Companion Diagnostic

    This article discusses four key topics any pharmaceutical company should consider for development and implementation of a Companion Diagnostic (CDx) for use with oncology drugs or biologics.   Introduction   The drug development process in the US is extremely long and costly. It is critical to get the patient a drug that is going to work for them. Especially in the oncology space, drugs for the most part are extremely toxic to the patient. Therefore, not only is th...
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    Administrative Law Overview

    This article provides an overview of federal administrative processes as they relate to the regulatory professional. The author reviews and emphasizes the importance of understanding the impact of the administrative process on federally regulated industry, with a focus on federal administrative law under the Administrative Procedures Act ( APA ). She reviews the APA impact on federal agencies, particularly on the United States Food and Drug Administration (FDA), wh...
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    FDA Announces new TRG Rapid Inquiry Program

    This article discusses the US Food and Drug Administration’s (FDA’s) Tissue Reference Group (TRG) new Rapid Inquiry Program (TRIP). 1 The author covers how the TRIP program is designed to work and explains elements of its regulatory changes under the Code of Federal Regulations, Title 21 Part 1271: human cells, tissues and cellular and tissue-based products (HCT/Ps). She describes product registration requirements and exceptions and highlights the program’s multiple benef...