Global Harmonization of Regulations for Medical Devices
by Michael Johns
, Project Manager | July 28, 2006
As reported on Medical Technology - Business Europe, 26 July 2006. (http://mtbeurope.info/news/2006/607031.htm)
Lbeck, Germany. The 10th annual GHTF (Global Harmonization Task Force1 ) Conference was held in Lbeck on June 2830 and attended by over 400 participants from 33 countries.
Note: The Global Harmonization Task Force (GHTF) was conceived in 1992 in responce to the need for international harmonization in the regulation of medical devices.
Under the motto "Design for Patient Safety in a Global Regulatory Model", representatives from government, regulatory agencies, industry, and users met in panels, workshops and plenary sessions to discuss the next steps towards globally harmonized regulatory requirements for medical devices.
The event was organized by the European Commission in Brussels, which currently chairs the GHTF. EUROM, the European Federation of Precision Mechanics and Optical Industries, hosted the event with the medical technology industry. Drger Medical was the cooperation partner.
In her opening speech, Georgette Lalis, current chair of the GHTF, Director of the European Commission, Directorate F Consumer Goods, Brussels, Belgium, briefly introduced the global regulatory model that is made up of GHTF guidelines. These guidelines outline requirements that must be met both before (premarket) and after a medical product is put on the market. Another main focus is the establishment of quality systems for medical device manufacturers, regulatory auditing, and verification criteria for the clinical claims for medical devices.
In his videotaped message, Gnter Verheugen, Vice President of the European Commission, underscored the special economic importance of medical technology and the need for worldwide harmonization of approval regulations. The idea of being able to introduce products all over the world as soon as they have been tested once, stated Verheugen, connects the GHTF not only to the guiding principles of the European Union, but also to the Hanseatic League, whose special significance for the hosting city of Lbeck, was well known.
Dietrich Austermann, Minister of Science, Economics, and Transportation from Schleswig-Holstein, Germany, also discussed this regional and historical relationship. He emphasized the economic importance of medical technology for the entire region and thanked the participants for making it possible to hold the international conference in Lbeck.
In his opening speech, Dr. Jeffrey B. Cooper, Director, Biomedical Engineering, Department of Biomedical Engineering, Massachusetts General Hospital, Boston, USA, noted that patient safety must always be at the forefront in the use of medical devices.