Benny Ons described EDMA's proposal to harmonize standards for IVD labeling using internationally recognized symbols nominated by manufacturers. He noted that while the IVDD encourages use of symbols in lieu of textual labeling, nations such as Japan are resisting the approach. In the case of self-testing devices, translation into the member state's official language becomes mandatory. In their transposition of the directive, most member states have opted to require IVD labeling in their official language, Ons noted. Examples include Danish, English, French, German, Italian, Portuguese, Spanish and Swedish.
Some countries require more than one language, including with stipulations English.
Switzerland's draft requirements include German, French and Italian, while Belgium's include French, Dutch and German. To clear such hurdles, manufacturers in Europe should revert to IVDD provisions suggesting more flexibility within the system, Ons asserted. We often go off and look to more sophisticated systems rather than just focus on what the directive tells us that we have to do. Inc. publications are protected by U.S. Copyright Law. Reproduction, photocopying, storage or re-transmission by magnetic or electronic means is strictly prohibited by law.