Bookmark and Share

Browse English Issue Headlines - August 2006

Examination of Mutual Compatibility

The European Medical Devices Directive (MDD, Directive 93/42/EEC) requires manufacturers of systems and procedure packs to determine the mutual compatibility of constituent (or component) devices that are intended to be used in combination. It does not, however, explain what is meant by mutually compatible. Haroon Atchia examines the nature of compatibility with respect to medical devices and the circumstances under which this might be mutual, and explores implications for manufacturers within the meaning of the MDD. More >>

Post-Market Compliance: FDA is Connecting the Dots...Are You?

Earlier this year, the US Food and Drug Administration’s (FDA's) Center for Devices and Radiological Health (CDRH) announced a new medical device postmarket safety programme intended to increase its ability to identify, analyse and act on postmarket information. The foundation of the programme rests on CDRH’s ability to effectively utilise and synergise its existing tools and resources used in its postmarket safety programmes, such as Medical Device Reporting and postmarket clinical studies. The likely result is an enhanced scrutiny of medical device manufacturers’ postmarket compliance practices to ensure that manufacturers are fulfilling their postmarket surveillance obligations and are appropriately reacting to and disclosing relevant safety information. In this article, Michael S Heyl summarises the FDA's Medical Device Postmarket Transformation Initiative, its likely impact on FDA enforcement efforts, and how device companies must ensure now more than ever that their quality systems, particularly their Corrective and Preventive Action systems, are sufficient to address potential postmarket medical device safety issues. More >>

Reporting & Vigilance - Obligations for EU Authorised Representatives in Germany, France and the UK

The European Active Implantable Medical Devices Directive, the Medical Devices Directive, and the In Vitro Diagnostic Medical Devices Directive include requirements for medical device manufacturers to report certain types of incidents to the Member State Competent Authorities. The European Union has set up a vigilance system to help safeguard the health of patients, users and others by reducing the likelihood of a serious incident involving a medical device being repeated in different places. Article 10 of the MDD describes a quite general approach to how adverse incident reporting should be handled and by whom. The Directive leaves it to the EU Member States to elaborate national reporting and vigilance standards, as well as chains of responsibility. In this article, Marija Capek describes the national vigilance and reporting regulations in Germany, France and the UK, outlines the obligations for the EU Authorised Representatives, and highlights the important differences between the national requirements of these countries. More >>

European Update

  • Clinical trials of advanced therapy products in the Czech Republic
  • Regulatory update on European-level group meetings
  • Regulation of advanced therapy medicinal products
  • Eucomed publishes human tissue engineering vademecum
  • Finland's NAM publishes strategy for 2006-2012
  • Third amendment to the German Medical Devices Act
  • German DRG proposals 2007
  • German medical technical aids register
  • DEHP-containing medical devices in Germany
  • BfArM issues recommendations for safe use of endoscopes
  • Industry to input in Joint Federal Committee procedures
  • Irish medical device Safety Notices
  • MEB in Netherlands awarded ISO 9001 certification
  • Fees for import/export certificates amended by Swissmedic
  • Draft Device Bulletin on IVDs used in combination issued by UK MHRA
  • Medical Device Alerts issued by the UK MHRA
  • UK guidance on IVD registration

More >>

US Update

  • CDRH's Medical Device Innovation Initiative
  • Olfactory test devices: classification
  • Public Health Notification on incorrect use of CGA 870 seals
  • Modernisation of the regulation of clinical trials and bioresearch monitoring
  • Exception from general informed consent requirements
  • Informed consent for certain IVD studies: final guidance
  • Manufacturer's mark on single-use devices: final guidance
  • Postmarket surveillance: final guidance
  • Real-time PMA supplements: final guidance
  • Electronic distribution of product information: final guidance
  • Review and inspection of PMAs: two draft guidance documents issued
  • Bayesian statistics in clinical trials: draft guidance
  • Ethylene oxide risk assessment

More >>

International

  • TGA fees and charges for 2006/7
  • Draft revision of Code of Good Wholesaling Practice
  • Conformity assessment certificates
  • New fact sheets published by Australia’s TGA
  • Amendments to Canada's radiation emitting devices regulations
  • Medical gas piping systems
  • Canadian standard for antimicrobial agents updated
  • Redundant testing and certification for devices in China
  • SFDA issues requirements for distributors
  • Other news from the Chinese SFDA
  • Hong Kong's proposed guidance on conformity assessment
  • Clarification on import and manufacture of medical devices in India
  • India proposes price controls on medical devices
  • Consultation drafts for implementation of the ANZTPA
  • Update on MoU between Canada and Australia
  • US implements Free Trade Agreement for Guatemala
  • US and Cambodia sign Trade and Investment Framework Agreement
  • Sweden and USA sign confidentiality arrangement
  • New proposed documents from GHTF SG5
  • New Zealand MoH's proposed guidelines on human tissue use
  • Unique Identification Number system for healthcare products in Thailand
  • Progress of the Thai FDA's Law Development Plan
  • Ministerial Announcement on contact lenses

More >>

Environment Update

  • Batteries and accumulators
  • Hazardous substances in electrical and electronic equipment

More >>

Standards Update

  • Harmonised EU standards
  • Modifications to the list of FDA recognised standards
  • Digital imaging and communications in medicine

More >>

Reference Information

  • Regulatory personnel on the move
  • Meeting report: 10th Global Harmonisation Task Force conference
  • Country overview: France
  • Elemental Essentials: European Notified Bodies
  • Overview of the Australian medical device regulatory system
  • Japan's Pharmaceutical Affairs Law

More >>