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Journal of Medical Device Regulation Issue Headlines - February 2010

Understanding the Promotion of Medical Devices in the EU

Understanding the rules governing the promotion of medical devices in the European Union (EU) can be complex for many reasons. Unlike medicinal products, for which a specific chapter on promotion is dedicated in Directive 2001/83/EC, EU legislation does not contain much in the way of direct rules and guidance that are specific to the promotion and marketing of medical devices. However, this does not mean that promotion of medical devices is not regulated. Their promotion is governed by several EU Directives of general application, by the national legislation of the EU Member States and industry codes of conduct and professional rules governing healthcare professionals. The challenge can be to identify applicable provisions, and the purpose of this article by Elisabethann Wright, Fabien Roy and Alexander Roussanov is to shed light on this regulatory framework. More >>

Overview of the Fourth Amendment of the German Medical Devices Act

On 21 March 2010, the requirements of amending Directive 2007/47/EC will come into force in Europe. In Germany, this Directive is being transposed into national law by the Fourth Amending Act on Medical Devices, the so called ‘4. MPG-Novelle’. However, the Fourth Amendment extends further than simply transposing the requirements of Directive 2007/47/EC; it introduces a number of national regulatory changes as well. Rainer Hill reviews the regulatory amendments that were published in the Law on the amendment of medical device regulations in July 2009 and discusses the other regulatory changes that still need to be introduced before 21 March 2010. More >>

Directive 2007/47/EC: A Detailed Treatise of the Clinical Data Requirements

Directive 2007/47/EC, which amended Directive 93/42/EEC inter alia, introduced numerous changes to the regulation of medical devices placed on the market with the CE mark. Haroon Atchia’s article presents a detailed treatise of the revisions affecting clinical data. More >>

Anti-Counterfeit Measures for Medical Devices

According to the World Health Organisation, the extent of counterfeiting is impossible to quantify. However, the number of incidents detected in 2007 increased to over 1500 (that is on average more than four cases a day), roughly a 20% increase with respect to 2006 and a 10-fold increase compared with 2000. These increases reflect improved detection and reporting capacity, but also indicate that the problem is growing in numbers. This article by Dr Ian Buckley looks at the different forms of counterfeiting, the types of devices affected and the measures currently available to combat the problem. More >>

European Update

  • Denmark sets device fees for 2010
  • New Competent Authority for medical devices in Estonia
  • Transfer of responsibility for devices at European Commission
  • CTSs for IVDs in Europe
  • Commission revises guidelines on clinical evaluation
  • MEDDEV on medical devices vigilance system revised
  • European guidance for Class I device manufacturers
  • Compulsory use of EUDAMED moves a step closer
  • Commission to report on reprocessing single-use devices
  • Distortion of competition in the importation of medical devices
  • Commission consultation about second-hand devices in France
  • Germany plans major overhaul of healthcare system
  • Ireland revises device-related registration application forms
  • Deadline extension for Italy’s Repertorio
  • Spanish legislative changes
  • MHRA regulatory fees: proposals for 1 April 2010
  • UK MHRA issues two guidance documents on vigilance systems
  • Medical Device Alerts in the UK
  • New NICE programme to evaluate medical technologies

More >>

US Update

  • Senate passes health reform bill
  • Classification of cardiac allograft gene expression profiling test system
  • Guidance on IVD 2009 H1N1 tests
  • FDA publishes guidance on medical imaging devices
  • Draft guidance documents relating to CADe devices
  • Draft guidance on IDEs and PMAs for heart valves
  • GMP for combination products: comment period extended
  • Re-opening of comment period for LASIK devices
  • Preliminary Public Health Notification for NPWT systems
  • Safety recommendations issued for endoscope processing
  • Update on UDI system for medical devices

More >>

International Update

  • Fee payments for inclusion in Argentinean Registry
  • Fourth bill to amend Australia’s Therapeutic Goods Act 1989
  • Australia proposes reclassification of joint replacement implants
  • Brazil specifies registration documentation for Class I/II devices
  • Health Canada amends QMS Certificate provisions of Regulations
  • Labelling recommendations for denture cleansers in Canada
  • Canadian guidance on electronic Class IV device licence applications
  • China plans to streamline device regulatory process
  • China drafts rules on GMP for devices
  • SFDA clarifies drug/device registration requirements
  • Inspection of Chinese clinical study institutions
  • First phase of IVD listing begins in Hong Kong
  • New guidance and Technical Reference for devices in Hong Kong
  • Hong Kong drafts guidance on clinical trial certificates
  • Australia and UK sign MoU on therapeutic products
  • AHWP seeks feedback on IVD regulations in member economies
  • GHTF documents
  • Korea proposes revision of technical document review process
  • New Zealand ‘Regulatory Statement to Foreign Government’
  • Peru approves new device law
  • Revised fee schedule for the Philippines
  • Tanzania launches first phase of device registration

More >>

Environment Update

  • European Member State reports on batteries and accumulators
  • Korea proposes standards for hazardous substances

More >>

Standards Update

  • Chinese standard drafted on medical face masks
  • Compliance with Egyptian standards for surgical implants
  • Harmonised EU standards
  • CEN enlarges its membership
  • Korea proposes revision of standards for certain devices

More >>

Reference Information

  • Regulatory personnel on the move
  • Country overview: Croatia
  • Elemental essentials: Australian Standards Orders
  • Meeting report: 14th AHWP conference

More >>