Product News

Regulations and Standards

  • Preparing for a US FDA Medical Device Inspection, Part 2
    US FDA is increasing quality system inspections of foreign medical device manufacturers. Part 1 of this article discussed why this is occurring, situations that European manufacturers should avoid, the importance of US FDA inspection preparation, and two topics that should be covered in inspecti...
    (May, 2012)
  • Illegal Implants, Ill-Conceived Laws
      We knew that the Poly Implant Prothèse (Pip) breast implant scandal would affect device regulations, but there was uncertainty about its scope. The so-called Pip resolution, drafted by the Environment an...
    (May, 2012)
  • Comparing EU and US Approaches to Regulating Clinical Decision Support Software
    Recently published guidance and, in particular, the decision trees it contains, can help manufacturers determine if their software should be regulated as a medical device. But the forthcoming recast of the medical device directives may add a few new twists and turns.
    (March, 2012)
  • Preparing for a US FDA Medical Device Inspection, Part 1
    US FDA is increasing quality system inspections of foreign medical device manufacturers. Part 1 of this article discusses why this is occurring, situations that European manufacturers should avoid, the importance of US FDA inspection preparation and two topics that should be covered in inspectio...
    (March, 2012)
  • Early Feasibility Medical Device Clinical Studies
    US FDA recently issued important draft guidance that describes new approval policies for early feasibility medical device clinical studies of significant risk devices. This article discusses the draft guidance and pilot programme that US FDA has initiated for testing the new policies.
    (January, 2012)
  • Pip Implant Scandal: Fix What’s Broke. Then Stop.
      Here are two headlines you don’t want to read: “Medical Devices and Chinese Toys Share Same Level of Safety Checks” and “The Terrifying Story of How a Former French Butcher Earned Millio...
    (January, 2012)
  • Guidance to Notified Bodies on Checking Clinical Evaluations
    There are two European documents that contain guidance for assisting Notified Bodies in conducting an effective assessment of clinical data and clinical evaluations. One is better known than the other. This article discusses both documents and their usefulness in ensuring acceptable clinical eva...
    (November, 2011)
  • MEDTEC Ireland Preview: In-house Regulatory Support Team Can Assist with Planning and Execution of Regulatory Compliance
    Teleflex Medical OEM, a full service medical product development and outsourcing business, now offers in-house regulatory support services for the licensing and registration of medical products. A dedicated regulatory team can assist clients, from start-ups to global companies, with the overall plan...
    (September, 2011)
  • PolyOne Helps Siemens Get the Lead Out
    Siemens collaborates with PolyOne and Reiter-HG Geiger to develop lead-free radiation-shielding components for its newest line of CT scanners.
    (August, 2011)
  • European Medical Device Usability Requirements
    Manufacturers marketing medical devices in Europe need to be able to demonstrate compliance with the newly clarified usability requirements introduced by Directive 2007/47/EC. This article discusses European usability requirements, relevant European standards and important ethical considerations.
    (May, 2011)
  • A Patently Absurd Situation
      There is a European Patent Office, but, as I am sure you are painfully aware, there is no single European patent. Instead, as noted recently in the Financial Times, there is simply a “basket of national p...
    (April, 2011)
  • In Vitro Diagnostic Performance Evaluation Studies: Part 1
    In vitro diagnostic medical devices are extremely important healthcare products for which performance evaluation studies can provide necessary evidence on safety and performance. Part 1 of this two-part article discusses European requirements related to performance evaluation studies. Part 2 will di...
    (April, 2011)
  • Plaidoyer en faveur d’un brevet unique
      Innover ou mourir : jamais cette expression n’a sonné aussi juste. Et ce n’est pas pure vue de l’esprit que de formuler un tel dilemme à propos des mécanismes de protectio...
    (March, 2011)
  • Serious Adverse Event Reporting During European Device Clinical Investigations
    In December 2010, two new European guidelines on medical device clinical studies were published. One covers serious adverse event (SAE) reporting while the other provides guidance on when clinical investigations should be conducted, together with general principles to be observed when conducting suc...
    (March, 2011)
  • Standards Objection
      The Formal Objection of the European Commission to 11 medical device standards has caused a certain amount of consternation and even alarm. The initiative has the potential to seriously undermine the EU regulat...
    (March, 2011)
  • Zertifizierung von Medizingeräten – Eine Hilfe auf dem Weg zur Konformität mit der IEC 62304 für Softwareentwickler
    Medizingeräte werden immer komplizierter; jetzt sind softwaregesteuerte Anwendungen ein integraler Bestandteil von ihnen, deren Ausfall zu Todesfällen oder schweren Personenschäden führen könnte. Trotz dieser erhöhten Komplexität reflektieren die Normen für me...
    (March, 2011)
  • The Notified Body Consultation Procedure: Part 2
    Manufacturers of medical devices incorporating ancillary substances should have a clear understanding of the consultation procedure that their Notified Body will have to follow. Part 1 of this article discussed the regulatory requirements and important guidance documents. Part 2 covers aspects of th...
    (January, 2011)
  • The Notified Body Consultation Procedure: Part 1
    Manufacturers of medical devices incorporating ancillary substances should have a clear understanding of the consultation procedure that their Notified Body will have to follow. Part 1 of this article discusses the regulatory requirements and important guidance documents. Part 2 will cover aspects o...
    (January, 2011)
  • Revised Medical Device Clinical Study Standard Introduces Sweeping Changes
    Manufacturers planning to conduct medical device clinical studies should be aware of the final draft international standard (FDIS) for medical device clinical studies, ISO/FDIS 14155:2010.
    (December, 2010)
  • New 400-W Power Supplies Meet Safety Requirements for Medical Use
    TDK-Lambda has added a 400-W system to its range of digitally controlled power supplies for medical applications. Combining 4-kV-ac reinforced inputto- output isolation with dual fusing and 1500-V-ac output-to-ground isolation, the EFE400M meets EN/IEC/UL/CSA 60601-1 safety approvals for medical equ...
    (October, 2010)
  • Continuing Evolution of the US FDA 510(k) Process
    US FDA is considering introducing some bold changes to the 510(k) review process. A new report describes these considerations, including the possible creation of a new Class IIb device subset.
    (October, 2010)
  • Newly Updated European Classification Guidance
    Determining the appropriate classification of a medical device is critically important. All manufacturers marketing devices in Europe should refer to a newly updated European guidance document on device classification.
    (September, 2010)
  • Compliance management system
    An integrated quality and US FDA– compliance management system is preconfigured to address medical device industry needs specifically and to exceed the GMP and 21 CFR Part 11 requirements for software. The modular approach of the EtQ Medical Device (GMP) FDA-management software solution maximi...
    (September, 2010)
  • European Device Regulatory Revolution: A Personal View
    Manufacturers entering the European medical device market in recent years may not be aware of the complexities of trying to achieve this objective 20 years ago. Significant progress has been made, although much remains to be done. This article provides a personal view of the innovative approach to m...
    (June, 2010)
  • The Evolving US 510(k) Review Process
    For many medical devices, the submission of a United States premarket notification, a 510(k), is no longer a routine process with a relatively predictable outcome. It can often be difficult, time consuming and costly to achieve. This article discusses Food and Drug Administration’s initiatives...
    (May, 2010)