An MD&DI January 1999 Column
Alan P. Schwartz, affiliated with mdi Consultants Inc. (Great Neck, NY), has been providing consulting services to the medical device industry for more than 20 years. Here, he answers several questions concerning the use of the CE mark.
My company manufactures and distributes products in the rapid diagnostic categoryfor example, HCG, pregnancy, hepatitis, and HIV tests. The lancets that are used to stick the patient's finger have the CE mark. Do the devices that perform the in vitro test also require the CE mark?
Although all medical devices, such as lancets, sold within the European Economic Area are required to have the CE mark on their label, the in vitro diagnostics used in test kits are covered by the IVD Directive (IVDD), which was adopted by the European Council of Ministers on October 5. The IVDD was published in the official journal of the European Commission on October 27, 1998. When publication occurred, the directive became law and manufacturers could start registering their IVD products.
Member states will have until December 7, 1999, to transpose the IVDD into national law. Beginning June 7, 2000, member states may start applying these provisions. IVDs that conform to current national legislation may still be marketed until 2003 and put into service for an additional two years.
However, experience has shown that this time frame is often not followed. In fact, Belgium has yet to transpose the Medical Devices Directive into its national law. Although your company could meet the IVDD's requirements any time between now and five years from the date of its publication, in vitro testing devices will not be required to have the CE mark until that final date. However, based on the medical device industry's recent experience, it may be a good idea to start complying with this new directive as soon as possible.
What are the labeling requirements for using the CE mark on the boxes for both natural and synthetic rubber examination gloves? Is there a required dimension for the CE mark?
Device labeling is one of the most misunderstood problems with the CE mark. Whenever possible, the CE mark should be a minimum of 5 mm in height. The CE mark should be printed as a distinguishable element of the device labeling. This is described in paragraph 13.3 in Annex 1 of the Medical Devices Directive.
Many manufacturers are also concerned about the number of languages and international symbols used in labeling. The greater number of international symbols used, the fewer foreign languages are necessary. A label should be printed in the language of the countries you intend to ship or distribute to. It appears that a total of six languages is an acceptable number. A manufacturer should determine which six languages to use for each particular product.
We manufacture Class II blood glucose monitoring systems. The European Commission ruled that all medical products sold in Europe as of June 13, 1998, must bear a CE mark to comply with the Medical Devices Directive. We already have CE marks under the directive EN 50082-1:1992. Is this enough to comply with the new regulations?
If your glucose-monitoring system is not an in vivo monitoring system, it would not fall under the Medical Devices Directive but rather under the new IVD Directive (IVDD), and you have time to implement the CE mark for your products (see the first question and answer for additional details). If the product is an in vivo monitoring device, a CE mark under the Medical Devices Directive is required. Be aware that complying with the MDD is different than complying with the EN 50082 directive, which covers electromagnetic compatibility (EMC) and has required electrical products to bear a CE mark since 1996. You should use the CE (EMC) mark on your label to comply with the EN 50082 directive, which would distinguish it from the CE marks required for the MDD or the IVDD.
Wayne Rogers is a principal investigator at Rogers Medical (Temecula, CA), and a member of MD&DI's editorial advisory board. He discusses two computer-related issues.
How are computer chips validated?
Computer chips per se are not validated. However, FDA has previously asked Intel, the manufacturer of Pentium chips, to perform a self-assessment to ensure that specific iterations were not repeated where intensive calculations and iterations occur. A device manufacturer should assess its requirements with the supplier to determine that the computer chips will meet the intended end use and provide the quality necessary. It should be part of purchasing control to provide evidence that the chips will meet their intended end use. The computer chips used in the final design must be included in the final verification or validation of the device.
Please provide some guidance on how to select a discrete-event-simulation software program that would be most appropriate for a medical device manufacturer. What companies offer this software?
The manufacturer is responsible for selecting the software program that is designed for an intended end use. There is no standard per se; FDA simply says that the program must work. The Internet is a good place to start gathering information. There are more than 80 manufacturers of discrete-event-simulation software programs. Contact some manufacturers and assess which of their programs best fit the application for your device's intended end use.
David Link is the executive vice president of Expertech Associates (Concord, MA). He discusses the importance of conducting risk analysis.
We manufacture Class I, low-risk devices and have received very few customer complaints involving injury. Can we use data showing this extremely low complaint rate per millions of devices sold instead of doing a risk analysis?
Analysis of complaints, while a valuable source of demonstrated risks under field conditions, is not a substitute for risk analysis. The design control section (820.30) in the FDA quality system regulations calls for risk analysis, where appropriate, when new products are being designed or major device modifications are being developed. The Medical Devices Directive, now mandatory in the EU, also includes requirements for risk analysis. Regardless of one's complaint experience, it would be prudent to conduct a risk analysis on all existing products to determine whether there are any risks that should be eliminated or reduced through redesign or managed by revised labeling. The risk analysis approach frequently used is found in the European standard EN 1441.
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