An MD&DI May 1999 Column
The five-year transition period has passed since the implementation of the Medical Devices Directive, and products must meet its essential requirements before they can earn the CE mark and be sold in the EU market.
All medical devices and their accessories that have been placed on the European Union (EU) market since June 15, 1998, have had to comply with the essential requirements set forth by the Medical Devices Directive, including the CE mark and labeling requirements. Directive 93/42/EEC was passed on June 14, 1993, with a five-year transition period during which member states were expected to pass legislation implementing whatever changes were needed to bring national requirements in line with the directive. Such legislation was also expected to create penalties for noncompliance.
Council Directive 93/42/EEC contains the basic framework for the regulation of medical devices in the European Union.1 EU directives are addressed to and are binding on member states insofar as the results to be achieved, but to be effective they must be implemented by each nation's laws. The directive of June 14, 1993, required the passage of such implementing measures by July 1, 1994, but multiple delays postponed the ultimate effectiveness of the directive. Belgium, the last country to adopt relevant legislation, only did so at the end of 1998. The legislation of the various member states is important in the context of the practical impact of the directive's labeling requirements, particularly regarding which language to use (see "National Implementing Legislation," below).
The directive's main objective is to harmonize national provisions regarding the safety, health protection, and performance characteristics of medical devices, including the relevant certification and inspection procedures. The different national systems had created barriers to unrestricted movement of medical devices within the EU marketplace. The directive states that all devices placed on the market must meet the "essential requirements" as detailed in Annex I. These requirements relate mainly to the design and construction of devices—their chemical, physical, and biological properties; construction and environmental properties; protection against radiation; and information supplied by the manufacturer, including labeling. Companies may ensure compliance with the essential requirements a number of ways, such as a full quality assurance system, product quality assurance, or a declaration of conformity, depending on the device's characteristics. The company may then affix the CE mark to its device, certifying that the device complies with the essential requirements and is thus entitled to move freely throughout the EU.
Article 22(4) specifies that, for a five-year transition period, member states could continue to accept the marketing and putting into service of devices that complied with those national laws in force in their territory on December 31, 1994. Therefore, until June 14, 1998, devices that complied with existing national rules could still be imported and sold in the EU. Thus, full implementation of the directive was postponed for five years.
The interpretation of article 22(4), and the notion of "putting into service" in particular, was the subject of extensive discussions among the member states and the European Commission toward the expiration of the transitional period. This led to the adoption of a commission communication regarding the transitional provisions of the directive as it applies to medical devices.2 This communication clarifies the phrase putting into service by providing that devices that had been placed on the market for the first time up to and including June 14, 1998, may, after that date, continue to be transferred to end-users and used in accordance with preexisting national rules. This communication was a nonbinding instrument, however, solely intended to clarify the matter until new legislation could be adopted.3 Such legislation was provided in article 21(2)(b) of Directive 97/79/EC, adopted on October 27, 1998, which governs the manufacturing and marketing of in vitro diagnostics.4 Under the new law, medical devices not bearing the CE mark that were placed on the market prior to June 15, 1998, may remain in distribution channels as long as they are delivered to the end-user no later than June 30, 2001. All medical devices placed on the EU market since June 15, 1998, must bear the CE mark and comply with the essential requirements contained in Annex I of Directive 93/42/EEC, including the labeling requirements described below.
Point 13 of Annex I of the directive details what information a manufacturer must supply when placing medical devices in the EU market. As a general principle, each device must be accompanied by as much information as is necessary for people to use it safely, taking into account the training and knowledge of the potential users. Certain basic instructions must appear on the label with more detailed copy to be included in the enclosed instructions. Instructions are not necessary for selected simple Class I or IIa medical devices if the devices can be used safely without them.
All medical devices must bear a label identifying the name and address of the manufacturer. For devices imported into the community, the label, outer packaging, or instructions for use must also contain the name and address of either the importer or the manufacturer's authorized representative established within the community. The label must contain several additional details, including information to enable the user to identify the device or other contents, as well as any operating instructions, warnings, or precautions to take. If the device's purpose is not obvious to the user, it must be clearly stated on both the label and in the instructions (point 13.4).
The instructions must contain several particulars, including the details required on the label, any side effects from use of the device, and, as a general rule, details for its correct use, including any specific precautions. In situations where conformity with the essential requirements must be based on clinical data, point 14 stipulates that such data must be established in accordance with Annex X.
Article 4(4) of the directive allows member states to "require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use." Consequently, the member states were required to specify in their implementing legislation the language to be used on any packaging and any labels. Naturally, although a number of options are provided, each country specified that their native language be mandatory. A sampling of the member state laws on labeling language is provided below.
NATIONAL IMPLEMENTING LEGISLATION
Article 5(3) of Italy's law decree provides that "the information given by the manufacturer to the user and to the patient, in accordance to Annex I (13) of the Directive, must be in Italian."5
The law decree does not specify what penalties would apply for noncompliance with the above requirement. However, it appears that penalties could be imposed under article 23 of the law decree, which provides for fines up to 10 million ITL (approximately $6000) and imprisonment up to six months for manufacturers that fail to provide adequate directions for use.
The UK Medical Devices Regulations of 1994, as amended, implemented the directive and came into force on January 1, 1995.6 Regulation 5 provides that devices placed on the market or put into service must comply with relevant requirements as specified in Annex I to the directive. Under article 5(5)a, "the essential requirements specified in Annex I with regard to information on the packaging and on any label are complied with only if such information is in English (whether or not it is also in another language and whether or not the device is for professional use)." However, instructions for use may be in another EU language, provided that there is "a clear statement in English stating the language in which instructions are given" (article 5(5)b).
If the product does not comply with the above requirements, article 19(7) states that a note will be sent by the authority "to the manufacturer, or his authorized representative, warning that person that unless the requirements are met, further action may be taken," including removal of the product from the market. The Consumer Protection Act 1987 provides for possible further measures, including fines and imprisonment.
The French law requires French to be used for labeling purposes.7 Section 9, article 665-43, provides sanctions against a manufacturer that places an irregular product on the market, i.e., economic sanctions and/or criminal and administrative proceedings.
Section 4, article 665-5 of Law n. 94-43 (January 18, 1994) states that a product that does not comply with the French legislation "will be removed from the market, by order of the administrative authority."
In The Netherlands, article 6(2) of the Decree on Medical Devices (March 30, 1995) provides that "the information referred to in the Annex I, point 13, which must be available to the patient, must be in the Dutch language."8 There is no mention in the Dutch implementing legislation about the penalties that would be applied in case of noncompliance of a device with the above requirements.
Article 4, paragraph 3, of the Swedish implementing legislation provides that all medical devices placed on the market must comply with the essential requirements covering information and labeling set out in Annex I to the directive.9 More detailed provisions are contained in the 1994 Regulation on Medical Devices, which provides that all devices that fall under the scope of Swedish law must be labeled in Swedish (Article 9).10
Penalties for noncompliance with these requirements range from the removal of the product from the market to criminal proceedings that may be initiated against the manufacturer. Specifically, in the case of an accident caused by a medical device that has not complied with all legal requirements, civil or criminal proceedings can be initiated against the manufacturer, its authorized representative, or both.
In Denmark, Order n. 734 (August 10, 1994) implemented the Medical Devices Directive. Specifically, part 2, article 2(2) of the order provides that "the devices must meet the essential requirements set out in Annex I to the Directive." With respect to language requirements, article 2(4) states that "the information set out in Annex I, Section 13, to the Directive shall be in Danish when a device reaches the final user." However, article 2(4) of the Danish legislation contains some exceptions, and states that "the National Board of Health may, however, in exceptional circumstances, allow such information to be in a language other than Danish." Exceptional circumstances are generally defined on a case-by-case basis by the National Board of Health.
Penalties imposed under part 7, article 17, in case of infringement with the above requirements provides that:
"(1)—Any infringement of sections 2, 3, 6, 7, 8, 9, 10, 11, 12, 13 and 14 is an offence under this Order and shall be punishable with a fine unless the offence in question carries a more severe penalty under any other legislation.
(2)—Where an offence hereunder is committed by a public limited company, a private company, a cooperative society or the like, a fine may be imposed on the company or society as a body corporate."
Device manufacturers that intend to place their products in the European market must carefully comply with all essential requirements in Annex I to Directive 93/42/EEC on medical devices, as well as with the member states' individual implementing legislation. The directive provides that member states may require the accompanying information to a medical device to be in their national language or in another community language. All member states require that safety information be provided in their official language to ensure understanding by the final user. The penalties for noncompliance with the above requirements vary from the removal of the concerned product from the market to economic penalties and, in some cases, to criminal proceedings.
1. Official Journal of the European Communities, No. L 169, July 12, 1993.
2. Official Journal of the European Communities, No. C 242, August 1, 1998.
3. Official Journal of the European Communities, No. C 178, June 6, 1998.
4. Official Journal of the European Communities, No. L 331, December 7, 1998.
5. Decreto Legislativo n. 46, del 24 febbraio 1997, G.U. 6 marzo 1997, Anno 138, n. 54.
6. The Medical Devices Regulations 1994 (S.I. 1994 n. 3017, Consumer Protection), as amended by AIMD Regulations 1995 (S.I. 1995/1671).
7. Loi n. 94-43, 18.1.1994 (Journal Officiel du 19.1.1994, p. 960)—Decret n. 95 292, 16. 3.1995 (Journal Officiel du 17.3.1995, p. 4176).
8. Besluit van 30 maart 1995—Staatsblad van het koninkrijk der Nederlanden nr. 243, 1995.
9. Lagen 1993:584 om medicintekniska produkter, June 3, 1993.
10. Föreskrifter och allmänna rad (SOSFS 1994:20) Medicintekniska produkter, November 28, 1994.
Larry R. Pilot is a partner with McKenna & Cuneo, LLP (Washington, DC), and a member of MD&DI's editorial advisory board. A version of this article was prepared as a report for Crimson Language Services (San Francisco).
Labels courtesy of Smith & Nephew Inc.