• Feature ArticlesFeature Articles

    Practical Solutions to Pharmaceutical Labeling Challenges

    Introduction   Have you ever wondered what the label management process entails? Or have you ever felt overwhelmed by the task of creating, editing and maintaining a product label while preparing for a new product launch or during product lifecycle management?   A health authority-approved pharmaceutical product label contains key information and data intended to educate healthcare providers and/or patients about how to safely use and prescribe a medication. As a...
  • Feature ArticlesFeature Articles

    Helen Brooke Taussig: An Often Overlooked Advocate for Drug Safety

    This article reviews the biography of Dr. Helen Brooke Taussig and discusses her successful efforts in the 1960s to prevent the drug “thalidomide,” the cause of wide-spread and serious birth defects in Europe, from being FDA-approved for use in the US. Introduction In the late 1950s and early 1960s, the drug thalidomide sent shock waves worldwide when it was proven that an allegedly harmless substance given to pregnant mothers as a sedative to combat morning sickness...
  • Feature ArticlesFeature Articles

    Are the periodic safety update reports a useful pharmacovigilance tool in the EU?

    This article discusses the importance of Periodic Safety Update Reports (PSURs) in the EU during drugs’ lifecycles. The author highlights the PSUR EU single assessment procedure, providing information on the stipulated timelines, what is published by the European Medicines Agency (EMA) and some aspects to be considered when writing a PSUR. A short reference is also made to the informal work-sharing procedure for follow-up for periodic safety update report single assessment...
  • Feature ArticlesFeature Articles

    Regulatory Strategies for EU MDR and EU IVDR Implementation

    September feature articles took an in-depth look at the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), where global medical device leaders explored the nuances of the new requirements and answered the industry’s most challenging questions. Individual articles covered the implementation of the regulations into national legislation, what the new regulations mean for substance-based medical devices, how to incorporate clinical evaluation re...
  • Feature ArticlesFeature Articles

    What is Sufficient Clinical Evidence According to the MDR?

    This article evaluates what is considered “sufficient clinical evidence” and covers its important place in Medical Devices Regulation (MDR). The author defines sufficient clinical evidence and discusses the kinds of clinical evidence required by MDR and what evidence can be considered state-of-the-art. Equivalent devices and benchmark/similar devices are discussed as well as performance studies.   Introduction   Presenting sufficient clinical evidence is an importa...
  • Feature ArticlesFeature Articles

    Implementation of Shared MDR Economic Operator Resources

    This article discusses how the Economic Operators (EOs) under the EU’s new MDR and IVDR regulations can organize themselves and cooperate in such a way that each of their obligations can be fulfilled without unnecessary repetition of action while providing objective evidence of completion and ensuring compliance. The authors suggest how cooperation can be realized, both in the case of internal and external economic operators (i.e., internal—forming part of the same corpora...
  • Feature ArticlesFeature Articles

    What EU MDR Means for Substance-Based Medical Devices

    This article provides a brief history of substance-based device regulation in context of the historical borderline medical device framework in Europe. It also outlines the impact of the MDR transition on CE certification of such devices and provides future perspectives on emerging issues in substance-based device regulation. The authors define substance-based medical devices, look at their regulatory evolution and speculate on what MDR means for the future of substance-ba...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    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   ...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    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...