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Publication of Revisions to the European Medical Device Directive Expected By End of 2007

London, 30 August 2007 -- The amendments to the European Medical Device Directive (MDD) are expected to be published in the Official Journal towards the end of 2007 once the legal and linguistic review has been completed and the final text has been adopted.

It is vital for companies to know exactly how the MDD has been amended and to understand how to meet its revised requirements. However, an updated version of the Directive itself is not expected to be published so companies will have to cross-refer to several documents to identify what changes have taken place.

To simplify the process, the Journal of Medical Device Regulation has published a supplement entitled Key Revisions to the European Medical Device Directive, 93/42/EEC. This 86-page, English language supplement discusses the various stages of the MDD revision and analyses the most important changes to the Directive, including those affecting:

  • the definition of a medical device;
  • the reprocessing of single-use devices;
  • clinical evaluation;
  • Notified Bodies and conformity assessment;
  • product classification;
  • drug/device combination products;
  • vigilance and post-market surveillance;
  • risk analysis and risk management.

The publication also includes a marked-up version of Directive 93/42/EEC, which precisely indicates the revisions to the Directive as at its first reading in the European Parliament.

About the JMDR

The JMDR is intended to educate, provide professional guidance, develop core competence of regulatory professionals, and promote debate on fundamental and topical matters within the medical device industry. In addition to publishing review and discussion articles by opinion leaders from the device community, the Journal summarises the news headlines from around the world and provides useful reference information in the form of charts and briefing documents. The Journal is a quarterly, subscription-only publication which is currently only available in electronic format.

For further information

For more information on the Journal of Medical Device Regulation please contact Marija Capek at Global Regulatory Press, tel: +49 (0)621 166 23 26 or visit the Global Regulatory Press website at www.globalregulatorypress.com.

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