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)
  • 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    US FDA recently issued important draft guidance that describes new approval policies for early feasibility medical device clinical studies of significant risk devices. This article discusses the draft guidance and pilot programme that US FDA has initiated for testing the new policies.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)
  • 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)
  • 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)
  • In Vitro Diagnostic Performance Evaluation Studies: Part 2
    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 discussed European requirements related to performance evaluation studies. Part 2 dis...
    (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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Clinical Evaluations and Clinical Investigations Under the Amended Medical Device Directive
    Directive 2007/47/EC1 amends the earlier Medical Device and Active Implantable Medical Device Directives. Amongst its new requirements is the need for more clinical data and more frequent clinical investigations in the conformity assessment of innnovative medical devices. Details of the changes and ...
    (September, 2008)
  • New Italian Device Registration Requirements
    A medical device manufacturer located outside Europe was informed by an Italian distributor that the European Authorised Representative must designate the distributor as the authorised entity when registering the manufacturer’s devices in Italy in a new online data bank. This is incorrect. Thi...
    (May, 2008)
  • Who Owns the 510(k)?
    Unfortunately, some medical device manufacturers, particularly those based outside the United States (US) are unaware of the business implications of submitting a 510(k) premarket notification to the US Food and Drug Administration. This article discusses information regarding the ownership and othe...
    (March, 2008)
  • Webinar Offers Free Expert Guidance on New Vigilance Procedures
    Originally Published EMDM January/February 2008 INDUSTRY NEWS A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5) was published in April 2007 by the European Commission and came into force on 1 January 2008. To help manufacturers and distributors navigate t...
    (January, 2008)
  • Scope of the European Medical Device Directives
    Can a product that incorporates nonviable human tissue be regulated as a medical device in Europe? Is a product that includes viable tissues or cells of animal origin regulated as a medical device? Is a product that incorporates a human blood derivative regulated as a medical device? This article di...
    (January, 2008)
  • Implementing New European Vigilance Procedures
    The new European vigilance guidelines come into force on 1 January 2008. In addition, the Directive amending the medical devices Directives, which includes some aspects of the vigilance system, was recently published. This article discusses the amendments concerning vigilance requirements, the new E...
    (November, 2007)
  • Auditing Device Clinical Studies For US Requirements
    Medical device manufacturers conducting clinical studies outside the United States (US) to support US regulatory submissions should be prepared to show that these studies are conducted in a manner that will be acceptable to the Food and Drug Administration. This article discusses the audits that can...
    (October, 2007)