European Union Directives EUROPEAN DIRECTIVES: A PRACTICAL REVIEW Keeping up-to-date on the European Union Directives is not easy. We are pleased to share some of the issues that we hear about. Also, a few newly proposed directives and amendments that have been approved. NOISE EMISSION IN THE ENVIRONMENT BY EQUIPMENT FOR USE OUTDOORS Official Name: Council Directive 2000/14/EC of 8 May 2000. Effective Date January 3, 2002. This Directive will have a big impact on the outdoor power equipment industry. In 1993 the EU Commission identified noise as a problem in urban areas and determined that 80 million EU citizens were negatively influenced by noise. The new Directive comes under the jurisdiction of the CE Marking regulation of 1993 and violation of the compliance requirements is a criminal offence and can ultimately result in a 5,000 pound fine and/or a 6 month jail sentence. To know what manufacturers need to know and do, GO HERE MEDICAL DEVICE DIRECTIVE Official name: Council Directive 93/42/EEC of June 14, 1993 concerning medical devices. Effective date: June 14, 1993 End of transition period: June 14, 1998 Firms that are in the business of recycling disposables are struggling with the fact that the original manufacturer has CE-marked the device for "one time use", which leads to the need to identify a "new manufacturer" of the device who again must CE-mark the product for re-use. All too often the cost of maintaining the CE-marked device status throughout the device's multi recycling phases eliminates any potential profit. The sad result is the closure of several recycling firms in Europe and the United States. Orthotic and Prosthetic Devices: Custom made or adaptation? Manufacturers of individualized devices should be aware of the following: Custom made devices are intended for sole use by a particular patient and produced in accordance with specifications prescribed by a qualified practitioner. A mass produced medical device that only needs adaptation is not a custom made device. Custom made devices do not carry a visible CE mark but remain subject to the Medical Device Directive (MDD) requirements. The manufacturer must issue a statement of conformity for each device stating the patient's name, device identification, responsible medical practitioners. Custom made (non-mass produced) medical devices must still meet the MDD requirements but are exempt from a CE mark being affixed to the actual device. These custom made devices must be reported at regular intervals to the competent authorities. Adapted devices are assembled and/or processed according to the manufacturer's instructions by an orthopedic practitioner (in Europe). This device must be CE marked by the manufacturer whose name appears on the product. If the product is processed without manufacturer instructions, or if the practitioner deviates from the manufacturer instructions, the practitioner becomes the manufacturer and must meet the MDD requirements and CE mark the device. The Metric Directive's impact on medical devices with a measuring function is clearly defined in the MDD, it states: The measurement made by devices with a measuring function must be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC (Metric Directive). IN-VITRO DIAGNOSTIC DIRECTIVE Official name: Council directive on in-vitro diagnostic medical devices. Effective date: 7 June 2000. PERSONAL PROTECTIVE EQUIPMENT DIRECTIVE Official name: Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment. Effective date: December 31, 1991 End of transition period: July 1, 1992 Manufacturers of some medical devices are surprised to learn that their products or devices are considered "personal protective equipment" . Classification is based on the "intended use" of the product. If the intended use is to treat, alleviate or compensate for a disease, injury or handicap; or relieve pain or defeat pain cycles it is a medical device. However, if the intended use is to prevent an injury, handicap or pain then it is definitely personal protective equipment. In some cases it can be both, for example, a glove for medical use in a patient's environment is a medical device, whereas a glove designed to provide protection against dampness, or heat or materials is personal protective equipment. MACHINERY DIRECTIVE Official name: Council Directive 89/392/EEC of 14 June 1989 on the approximation of the laws of the member States relating to machinery. Effective date: January 1, 1992 End of transition period: January 1, 1995 Re-published as 98/37/EC, 22 June 1998 to include all amendments. The definition of a machine is an assembly of linked parts or components, at least one of which moves, joined together for a specific application. Self-certification is permitted for all machinery except for those listed in Annex IV of the directive. Ways of demonstrating compliance with the machinery directive include (1) complying with the harmonized standards and preparing a technical file; or (2) observing national standards/ codes. Both methods require: test evidence or statements; support documents showing how a product complies; and engineering calculations. Complying with the 48 Essential Health and Safety requirements of the Machinery Directive is mandatory for all machines; additional directives that often apply to machinery are the Low Voltage Directive and the EMC Directive. ATEX DIRECTIVE Official name: Council Directive 94/9/EC of 23 March 1994 on the approximation of the laws of the member states relating to equipment and protective systems in potentially explosives atmosphere Effective date: 1 March 1996 End of transition period: 1 July 2003 This directive applies to equipment and protective systems intended for use in potentially explosive atmosphere. Safety devices, controlling devices and regulating devices intended for use outside the potentially explosive atmosphere, but which are required to contribute to the safe functioning of equipment and protective systems, are also covered by the scope of the directive. All currently certified equipment will have to be re-certified against the Directive. LOW VOLTAGE DIRECTIVE Official name: Council Directive 73/23/EEC of 19 February 1973 on the harmonization of the laws of Member Sates relating to electrical equipment for use within certain voltage limits (LVD). Effective date: 19 February 1973 End of transition period: 1975 This is one of the oldest directives and applies only to equipment in the voltage ranges of 50 to 1000V AC and 75 to 1500V DC. The requirement for affixing of the CE-mark was added on January 1, 1995. ELECTRO MAGNETIC COMPATIBILITY (EMC) DIRECTIVE Official name: Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member states relating to electromagnetic compatibility, Effective date: 1-1-92 End of transition period: 1-1-96 This directive applies to all electrical and electronic appliances, equipment and installation containing electrical and/or electronic components liable to cause electromagnetic disturbance or the performance of which may be affected by such disturbance. EMC passive equipment such as cables, cabling accessories, connectors etc. are excluded from the scope of the EMC directive. In a recent communication received from one of the major EMC test houses in Germany it stated that of the 50,000 imported pieces of machinery tested annually 30% fail the test. Manufacturers should place more emphasis on testing in the USA before shipping. Luckily the availability of EMC, on-site, testing capability is growing. Many of these services are staffed by highly qualified EMC test engineers trained by the US Navy during the Gulf War mine sweeps. PUWER DIRECTIVE Official name: Council Directive 89/655/EEC of 30 November 1989 concerning the minimum safety and health requirements for the use of work equipment by workers at work. Effective date: November 30, 1989 End of transition period: December 31, 1992 This directive refers several times to compliance with the 48 essential health and safety requirements of the machinery directive as they relate to the use of equipment by workers at work. It states that the employer shall pay attention to hazards posed by the use of work equipment. This clearly places the responsibility of purchasing correctly CE-marked equipment on the buyer's or end-users shoulders. Recent articles about the year 2000 problems have also referred to this directive, specifically to regulation 18, which requires employers to ensure, as far as reasonably practicable, that all control systems of work equipment are safe. PROPOSED CONSUMER GUARANTEE DIRECTIVE During an EU Consumers Council meeting on April 23 in Luxemburg, a political agreement was reached regarding this directive covering the sale and guarantee of consumer goods. This proposed directive is a "co-decision process" directive, meaning that both the Parliament and the Council need to agree to the text before it is adopted by the EU Council of Ministers. In this same meeting, both Germany and Denmark voted against this political agreement and The Netherlands abstained. The other 12 countries agreed on the revised text and have sent the proposed directive back for a second reading to the European parliament. Germany voted against this concept as they find the two year guarantee period too long (it is presently 6 months in Germany), and they also opposed the inclusion of secondhand goods. Denmark did not agree with the two year guarantee period either. (Denmark presently has one year.) The latest political compromise outcome is: 1) The legal guarantee period for consumer goods will be two years. 2) The legal guarantee will apply to both new and secondhand goods. 3) The consumer will have the choice, at first, between repair and replacement, without charge, of the faulty consumer good (within a reasonable time and without major inconvenience for the consumer). Or, there will be a choice between price reduction and cancellation of the contract, if the first two solutions prove impossible or out of proportion compared to the value of the product, or in terms of cost for the seller. 4) The seller alone is considered directly responsible for ensuring that the goods comply with the contract, and it is the seller who is responsible for any defect. (Some delegations wanted to include producers' liability, but they were overruled.) 5) The time limit in which the consumer may provide notification of product non-performance as stated in the contract, will be two months from the date when he noticed the fault. However this two month time limitation enforcement is optional for the national governments. 6) The time for transforming the directive into national law will be three years. The text will now go for a second reading in the EU parliament, as mentioned before. They will not receive the EU agreed consumer council text before June or July 1998 so an agreement cannot be expected before December 1998. This is the legal three month period for the second reading with an additional one month which may be requested. By that time the EU Presidency will be in the hands of the Austrians, which according Council meeting attendees, will be favorable to industry generally. Presently there are two potential scenarios: (1) the parliament approves the text as was agreed by the EU consumer council and then the council will adopt the directive within the next six months after the parliament has made its decision (most unlikely). (2) There will be no agreement in the parliament on the present EU consumer council's text and the council will receive for their second reading a revised text back from the parliament (most likely). By then there will have been two readings in both institutions without reaching an agreement on the text. A conciliation committee will be set up if the differences between both texts after the second readings are major. This committee will negotiate a common text. However, if they are unable to achieve this the council can make a unilateral decision to adopt the text. This text will not become law if the parliament rejects the final text within six weeks. One learns from this lengthy process that this directive will probably not be adopted by either institution during the next 12 months. It may also mean that the transition of this directive into a member state law will probably not happen before January 2002 but more likely, not before January 2004. E-mail: qnet@ce-mark.com