Global Harmonization

An international task force works to ease trade.

Medical device manufacturers are concerned about international roadblocks as they attempt to sell products overseas. In order to market medical devices in the European Union (EU), for example, device makers must first gain approval to affix their products with a CE mark, which shows that the products comply with the EU's medical device directives. Progress is being made toward the global harmonization of standards and regulations, which will help companies satisfy all requirements. The Global Harmonization Task Force (GHTF) is working to ease trade among countries with different medical device regulations and to bring closer the possibility of universal regulations.

Paul Brooks, head of a notified body for BSI

Other efforts are being made to help device makers market their products internationally. FDA and the EU have established a system that allows for mutually recognized assessment bodies to audit and inspect the devices of one country against the requirements of the other. This mutual recognition agreement (MRA) authorizes conformity assessment bodies (CABs), which are trained in the requirements of the various markets, to assess products to be sold in those markets. CABs in Europe will be trained to assess against the regulations of FDA, specifically premarket notification reviews and quality system regulation inspections. Conversely, CABs in the United States conduct inspections to satisfy the EU notified bodies, including the requirements for CE marking of medical devices. When the CAB has reviewed a product or quality system, the product or system must then be brought before the regulatory authority in the destination country for final market clearance.

The advantage of the MRA is that medical device manufacturers are able to work with an agency in their home country and in their own language. On the other hand, most U.S. medical device manufacturers have already received their CE mark to sell products in the EU by working with notified bodies in Europe. Thus, the MRA may have more benefits for EU manufacturers who want to market their products in the United States. It seems as though U.S. manufacturers have little reason to use the system.

U.S. companies, as well as those from other countries, would benefit from a consistent approval system for all countries involved in international trade. The MRA does not harmonize the regulatory systems; it maintains independent systems for regulating medical devices.

To combat the underlying problems with the MRA and other trade agreements, the GHTF is made up of representatives from all over the world with the common goal of harmonizing global requirements. The group is attempting to harmonize the elements of the regulations, without trying to put in place full recognition agreements that are difficult to manage.

To accomplish this, the GHTF is split into four study groups. The first deals with premarket approval of products. The second studies medical device vigilance and postmarket surveillance. The third study group deals with the quality systems standards such as ISO 9000, ISO 13485, and ISO 11607. The fourth focuses on quality systems inspections to determine compliance with requirements. With these four groups in place, the GHTF hopes to develop a globally recognized, consistent method for assessing products and quality management systems.

Harmonizing global standards has potential benefits for the medical device industry. Through the work of the International Organization for Standardization and the International Electrotechnical Commission, standards are being developed and accepted that will enable products to circulate more freely in the international marketplace. Coordinating global regulations will take years, but the GHTF provides a workable solution to international trade problems.

For more information, please contact BSI Inc., the North American division of the British Standards Institution (BSI), at 800/862-4977. To learn more about the GHTF, visit http://www.ghtf. org.

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