Regulations and Standards

  • RoHS Is a RoHS Is a RoHS
    Medical and in vitro diagnostic device manufacturers soon will need to comply with European requirements restricting the use of certain hazardous substances in electrical and electronic equipment. By: Maria E. Donawa
    (November, 2013)
  • Medtech's New Power Trio: Turkey, Indonesia and Iran
    Overshadowed by the BRIC countries, Turkey, Indonesia and Iran don’t get the attention they deserve. Here’s why they should be on the global medtech industry’s radar.
    (November, 2013)
  • Design Rationale and Medical Devices: Why Is it Designed and Manufactured the Way it Is?
    Design Rationale is a method to capture and to explain why a medical device is designed and manufactured the way it is. This means of documentation can not only support problem solving in the design process but also help with regulatory approval and in case a product needs to be recalled. By: Jee...
    (November, 2013)
  • The Critical Task of Selecting a Notified Body, Part Two
    Since the dawn of the European medical device directives more than 20 years ago, the process of selecting a Notified Body has been an important undertaking. In the current regulatory environment, this process is even more critical. Part one of this article discussed Notified Body regulatory requirem...
    (August, 2013)
  • How to Select a Notified Body, Part One
    Since the dawn of the European medical device directives over 20 years ago, the process of selecting a Notified Body has been an important undertaking. In the current regulatory environment, this process is even more critical. Part one of this article discusses Notified Body regulatory requirements ...
    (July, 2013)
  • A Shortcut to Medical Device Reimbursement in Germany
    A recent law offers medical device manufacturers a pathway for securing more-timely reimbursement for new medical diagnostic and treatment products used in physician offices. By Amir Inbar, Mediclever Reimbursement Consultants
    (June, 2013)
  • Memo to EU Member States: Don’t Derail UDI
    WELL, THAT WAS FAST. At its March 2013 meeting in Nice, France, the International Medical Device Regulators Forum (IMDRF) announced that it would release guidance on a unique device identification (UDI) system for public consultation in the “near future.” That is usually code for, &ldq...
    (May, 2013)
  • US FDA Publishes Proposed Rule on Non-US Clinical Studies
    If the proposed rule on US FDA requirements for accepting data from medical device clinical studies conducted outside the United States becomes final, manufacturers will face significant new requirements.
    (May, 2013)
  • New US Regulation on CGMPs for Combination Products
    US FDA has recently published its long-awaited regulation on current good manufacturing practices (CGMPs) applicable to combination products. The regulation becomes effective on 22 July 2013 and applies to combination products already on the market in addition to newly developed products.
    (April, 2013)
  • Keeping Your IP Fit and Healthy
    To achieve maximum competitiveness medical device companies should review their intellectual property on a regular basis.
    (March, 2013)
  • Make Your Voice Heard via UK Public Consultation on New Medical Device Legislation
    The UK Medicines and Healthcare products Regulatory Agency has launched a public consultation that presents its views and requests opinions from stakeholders on the newly proposed medical device legislation. This article discusses the consultation and suggests that readers consider responding.
    (January, 2013)
  • The Good, the Bad and the Ugly
    There was plenty to talk about at MedTech Forum 2012, from the new medical device regulations to business models that are “changing fast and forever,” to quote Chris Llewellyn from McKinsey & Co. Here are some random thoughts inspired by the meeting, organised by Eucomed and the Eu...
    (October, 2012)
  • Proposed New European Medical Device Regulations
     After more than 20 years of broadly accepted success, the European directives on medical devices are in line for a major overhaul. The European Commission has recently published its proposals for regulations on medical devices and in vitro diagnostic medical devices. This article highlights se...
    (October, 2012)
  • Tech Barbarians at the Medtech Gates
      Some 40,000 medical-related apps are available for download, and countless more are on the way, which begs the question: How do you reconcile the regulatory requirements that govern medical devices with the fas...
    (July, 2012)
  • Proposed Guidance on IVD Clinical Evidence and Performance Evaluation
    Manufacturers of IVD devices should be aware of three proposed Global Harmonization Task Force guidance documents on clinical evidence for IVD devices. The documents cover definitions and terminology, determining scientific validity, performance evaluation and clinical performance studies.
    (July, 2012)
  • Drug-Device Combinations: Which cGMPs to Follow?
    The evolution of the medical device industry over the last five years has been rapid with an increasing number of drug-device combinations emerging into the marketplace. With these novel products come the novel challenges of satisfying the relevant notified bodies and competent authorities throu...
    (June, 2012)
  • 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)