ABSTRACT
Labeling means different things in different countries. The European Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC (the MDD) does not define labeling per se or its constituent components. Apart from the ubiquitously present stipulations in the MDD when and where the CE-marking must be affixed, par. 13 of Annex I (Essential Requirements) spells out in great detail which information must be supplied by the manufacturer. The elements of labeling mentioned there are limited to the information accompanying the device (i.e., package insert or instruction for use, which includes a manual for large or complex devices) and the label(s) proper for individual units either on the product itself or on the unit packaging, on the “sales packaging.” Terms such as “shipping carton,” labeling for double packaging, and other commonly used designations have not been codified in the law. One of the key elements of labeling in the near future will be the use of a UDI, a unique device identifier. While the idea itself makes eminent sense, it must be feared that in absence of a welldefined electronic structure allowing for the proper handling and management of the huge quantity of data influx, the objective of the electronic tracing of individual products from the manufacturer to the user will stay an illusion for many years to come. To this end, the Global Harmonization Task Force (GHTF) has issued guidance on UDI [1] (UDI System, September 16, 2011) which implores countries to consider the GHTF guidance in promulgating regulations on UDI. It would appear the USA FDA will be the first in line to publish a draft rule (expected in the fall of 2011) [2]. The FDA has published this draft UDI as a proposed rule (Federal Register, Vol. 77, No. 132, 10 July 2012). https://www.gpo.gov/fdsys/pkg/FR-2012-07-10/ html/2012-16621.htm; however, the EU, with their revision of the medical devices directives, will similarly seem to require UDI [3]. The draft Medical Device Regulation introduces the use of UDI. https://www.gpo.gov/fdsys/pkg/FR-2012-07-10/html/201216621.htm. As the concept of “labeling” in Europe means different things in the respective EU Member States, vastly different regulatory regimens
exist. France, Germany, the United Kingdom, and even Italy and Spain show an increasingly strong enforcement of their respective laws concerning promotion, including the Internet. The enforcement of a harmonized label content (especially concerning intended uses, indications, and claims as well as contra-indications) is just beginning, enhanced by the COEN (Committee of Enforcement), and lately by the CMC (Central Management Committee), two Member State-only committees that promotes a coordinated approach toward interpretation and implementation of laws and regulations for devices. Based on Title 21, Section 820.1 of the Code of Federal Regulations (CFR), the United States has had a long and historically driven tradition of strong and sometimes even heavy-handed enforcement of labeling compliance. Labeling in the United States means any written or verbal expression of information accompanying or concerning the device and controlled in any way by the manu-facturer, including but not limited to labels in the strict sense, promotional materials, any verbal statement by company representatives, the Internet, and even information about products not yet approved but shown to the public at trade fairs. The FDA is strictly monitoring the compliance of labeling content with the claims approved. Any proof that a manufacturer is intentionally or commercially exploiting the often gray area of “off-label” use can lead to draconian fines and/or criminal prosecution. In Korea, a medical device label is one attached onto the outer most packaging though there does not appear to be an official reference to the definition of labeling. In China, SFDA Order No. 10 regulates the labeling (Instructions, Labels, and Packaging of Medical Devices). There are 23 Articles in the Order. Countries such as Singapore and Hong Kong, which use more GHTF (or AHWP)-like regulatory systems, have similarly defined labeling as in the EU.
