Regulations and Standards

  • Revised European Guidance on Clinical Evaluations, Part 1
    A significantly revised European guidance document has been published that will dramatically affect how medical device companies address the European clinical evaluation process and how Notified Bodies will assess compliance with clinical evaluation requirements. Part 1 of this two-part article will...
    (March, 2010)
  • New European Device Clinical Requirements: Part 2
    Part 11 of this two-part article discussed the requirements on clinical data and evaluation that will come into effect on 21 March 2010. Part 2 covers the revisions of requirements on clinical investigations, the European database, postmarket clinical follow up and conformity assessment of clinical ...
    (February, 2010)
  • Sterilisation Industry News
    Some of the important issues facing the sterilisation of medical devices include the sterilisation of combination products, and improvements in the processes being employed. This article outlines recent developments in X-ray sterilisation and low- and medium-energy electron beam capabilities, and re...
    (February, 2010)
  • Mixed Media
    New Literature, CD-ROMs, Videos and Podcasts
    (January, 2010)
  • New European Device Clinical Requirements: Part 1
    By 21 March 2010, companies marketing medical devices in Europe will need to demonstrate compliance with new and clarified European requirements on clinical data and other clinical requirements. Part 1 of this two part article discusses the requirements on clinical data and evaluation. Part 2 will a...
    (January, 2010)
  • Clinical Studies in Italy
    The requirements for conducting medical device clinical studies in Europe are not identical in all Member States. That is, variations exist in the way that the requirements in the European Directives are interpreted and enforced. This article provides an overview of the requirements that currentl...
    (November, 2009)
  • Setting Standards
    New Protocols Will Test Effects of RFID Systems on Medical Devices
    (November, 2009)
  • US Regulation of Combination Products
    The successful launch of a combination product in the United States (US) will depend on how well a company understands applicable US regulations and policies, which differ in important ways from requirements in Europe. This article provides an overview of useful information on the US regulation of t...
    (October, 2009)
  • New European Guidance on Borderline Products
    The European Commission has recently updated an important guidance document on determining whether or not a medical product is subject to medical device or medicinal product regulations. In addition, a new manual that provides practical examples has also been issued. This article discusses these doc...
    (September, 2009)
  • Patient Protection at Risk in IEC 60601-1 3rd Edition
    Engineers developing medical electrical equipment in accordance with IEC 60601-1 3rd edition are in immediate need of short- and long-term solutions to avoid potentially hazardous designs as a result of misinterpretation of the requirements. Several options are described to ensure consistency and sa...
    (September, 2009)
  • Meeting US and European Supplier Control Requirements
    Medical device manufacturers operating under European quality system requirements are sometimes surprised to learn that their supplier control procedures do not fully meet United States (US) requirements. This article discusses important differences between US and European requirements for controlli...
    (May, 2009)
  • Developments Across the Industry
    THIS ISSUE Directive threatens the future of MRI The European Commission (EC) is under pressure to amend the Physical Agents (EMF) Directive, which if adopted into national legislation in its current form, would restrict the use of MRI scanners in medical practice and research. The...
    (May, 2009)
  • Product and Package Stability Studies: The Application of FDA Guidance
    The United States Food and Drug Administration provides guidance on physical tests to employ to demonstrate that packaging maintains the sterility of products throughout their shelf life. This article discusses what this means in practice for medical device manufacturers.
    (May, 2009)
  • Product and Package Stability Studies: The Application of FDA Guidance
    The United States Food and Drug Administration provides guidance on physical tests to employ to demonstrate that packaging maintains the sterility of products throughout their shelf life. This article discusses what this means in practice for medical device manufacturers.
    (May, 2009)
  • Avoiding Surprises When Implementing a Single Quality System
    European medical device manufacturers are sometimes surprised to learn that operating ISO 13485 alone is not sufficient to meet United States (US) quality system requirements. This article discusses important considerations for meeting US and European requirements when operating under a single quali...
    (March, 2009)
  • Assuring Regulatory Compliance without Compromising Innovation
    A new product development system automates routine processes and helps to avoid “deliverable document syndrome”
    (March, 2009)
  • Addressing European Environmental Legislation
    Medical device companies need to meet European requirements designed to protect the environment. The deadlines for some of the requirements have already passed. This article discusses a European Regulation and two Directives, and a means for meeting environmental requirements in an effective manner.
    (January, 2009)
  • Developments Across the Industry
    THIS ISSUE The pump that also repairs hearts A biologic ventricular assist device (VAD) has been designed with the ability to capture, grow and administer stem cells that will regenerate and restore damaged myocardium. A traditional VAD is used to partially or completely replace the fun...
    (November, 2008)
  • The Evolving Process of European Combination Product Review, Part II
    A new European guideline on drug-eluting stents (DES)1 introduces for the first time detailed information that European drug authorities should review concerning the medicinal substance that is incorporated into this type of drug–device combination product. Part I of this article discussed Eur...
    (November, 2008)
  • The Evolving Process of European Combination Product Review, Part I
    A new European guideline on drug-eluting stents (DES)1 introduces for the first time detailed information that European drug authorities should review concerning the medicinal substance that is incorporated into this type of drug-device combination product. Part I of this article discusses European ...
    (October, 2008)
  • Shows and Conferences
    INDUSTRY NEWS Forum for Materials Testing to Be Held in Ulm, Germany The 17th annual Forum for Materials Testing will provide information on mechanical testing to industry professionals. Held 13–16 October in Ulm, Germany, the trade show will enable visitors to learn about...
    (October, 2008)
  • Developments Across the Industry
    THIS ISSUE Orthopaedic implants increase momentum Demand in United States for orthopaedic implants will grow by 8.9% per annum to be valued at nearly US$22 billion in 2012, according to a report from Freedonia. The four major product sectors all offer good prospects. The market for reco...
    (September, 2008)
  • Addressing US and European Device Testing Requirements
    Medical device companies do not always realise that United States and European test requirements can be significantly different. Not addressing these differences can be costly when retesting or device redesign becomes necessary. This article discusses some of these differences and ways to help avoid...
    (September, 2008)
  • Clear SL Resin Achieves USP Class VI Designation
    Sourcing Hotline A clear water-resistant stereolithography material has passed stringent biological tests and achieved a USP Class VI rating. Watershed XC 11122, developed by DSM Somos (Elgin, IL, USA; www.dsmsomos.com), has been widely used in the medical device industry since ...
    (September, 2008)
  • The MDT Five-Minute Interview
    Medical Device Technology’s (MDT) series of interviews offers a range of personal perspectives on the diverse and dynamic medical device technology industry. Here, we talk to Patrick Sabaria.
    (September, 2008)