Understanding European Regulations for Medical Electronics

Roger Smith

For the many U.S. medical electronics companies that are intending to move into the European market or are already established there, understanding the European regulations that determine product acceptance is essential.

On June 15, 1998, a set of harmonized standards for all medical devices will become mandatory; after this date, all medical devices will have to comply with these regulations in order to enter the European market. During this transition period before the medical device regulations become mandatory, there is some confusion about whether medical electronic devices must be regulated under general electronics rules that are already in force. To better understand this present state of medical electronics regulations, some recent European history is helpful.

The EC, EU, and the CE Mark

The European Economic Community (EEC) treaty was adopted in 1957 to promote freedom of movement for goods, persons, services, and capital among the participating countries, or European Community (EC). Article 30 of the EEC treaty prohibited trade restrictions among member states, but Article 36 provided an exception--it allowed countries to exclude products that the countries determined to be dangerous to the safety of people or the environment. To prevent the misuse of this exception, the EC agreed on harmonized standards, or directives.

Beginning in 1985, members of the EC began to work to revise these directives, to make them less proscriptive and offer manufacturers more options for compliance. In the next several years, these New Approach Directives began to come into force, listing the product requirements that the EC determined were essential for acceptance. To easily identify products that were in compliance with the appropriate directives, the EC adopted the Communité Européan (CE) mark.

The CE mark is the assurance that a manufacturer has taken all the necessary steps to comply with the regulations of the applicable product directives. It must be supplemented by a letter of conformity that is signed by an authorized officer or agent of the company and that contains the product information required by the applicable directives. Depending on the type of product, the assistance of a notified body may be necessary for CE marking. The notified bodies are companies appointed by the national competent authorities, often the ministries of health, to determine whether products comply with the directives.

In 1991, the Maastricht Treaty revised the EEC agreement to promote close economic, political, and even military ties among European countries, creating the European Union (EU), which now includes 15 countries. The current member states of the EU are Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden, and the United Kingdom. Under the 1993 European Economic Area treaty, Iceland, Norway, Switzerland, and Liechtenstein also agreed to require the CE mark, although they are not members of the EU.

For medical electronics manufacturers, the most important of the new directives, the Medical Devices Directive (MDD), became effective on January 1, 1995, with a mandatory compliance date of June 15, 1998. The adoption of the MDD means that it will be illegal to ship medical devices that do not comply with the directive to the 18 participating countries after June, 1998. If the products properly display the CE mark, however, free trade will be upheld by each member state unless there is adequate reason to suspect noncompliance. Affixing the CE mark without meeting all requirements is an offense under the national regulations of each EU member, and is punishable by fines, blacklisting, and possible criminal proceedings.¹ Until 1998, it is not mandatory for products to bear the CE mark, but electrical products shipped now to the EU without the mark could be held in customs or rejected at the port of entry until the safety of the device can be determined.

There are two additional directives that apply specifically to electronics: the Electromagnetic Compatibility (EMC) Directive, which is already in force, and the Low Voltage Directive (LVD), which will be in force after January 1, 1997.

Directives for Electronics: EMC and LVD

The EMC Directive.This directive came into force in 1996 and is applicable to all the electrical devices that are shipped to the EU; however, in the period before the MDD becomes mandatory, there are differing opinions on whether medical electronics must follow this directive. One belief is that medical electronics need only meet the current national EMC requirements for the member state in which the products will be sold. However, the most widely held view is that medical electronics that do not comply with the MDD must meet the EMC Directive by using the medical equipment requirements that are given in EN 60601-1-2, a standard that is applicable to all electronic equipment provided as part of a medical system. Meeting the EMC Directive for an electrical medical product would allow a manufacturer to affix the CE mark even before completing the entire MDD process.² Of course, the letter of conformity would indicate which standards were used to determine compliance.

In Europe, compliance to the various directives is required for all electrical, electronic, and medical equipment. As of January 1, 1996, EMC testing to EN 60601-1-2 is mandatory and CE marking must be affixed.³

However, the United Kingdom's position is an exception to this majority opinion on EMC compliance. The Directives Bulletin No. 15, released by the UK competent authority, the Medical Devices Agency, states that "the EMC Directive provides that, where harmonized protection requirements are subsequently set for particular types of apparatus by product-specific directives [MDD], then the EMC Directive ceases to apply to such types of apparatus when these other directives enter into force." The bulletin concludes that, "Accordingly, the provisions of the EMC Directive ceased to apply to devices coming within the scope of the MDD as from 1 January 1995."⁴

Many manufacturers and standards bodies do not agree with the UK position. For example, David Lohbech of TÜV Rheinland North America (Skokie, IL) says that medical electronics will not be exempt from the EMC Directive until after the MDD becomes mandatory on June 15, 1998.

Chris Harvey, director of the EMC lab at MET Laboratories (Baltimore, MD), also says that medical electronic devices that are intended for European markets must comply with the EMC Directive.

The LVD. This directive applies to electronics that use or produce voltages of 50­1000 V ac or 75­1500 V dc and will come into force on January 1, 1997. Although Annex II of the LVD states that electrical equipment intended for radiological and medical purposes is not within its scope, compliance with the directive may be required by some countries for products that do not already comply with MDD.

Alan Kirwilliam, director of AMTAC Certification Services (Broadheath, Altrincham, Cheshire, UK), a notified body, notes that although the UK will not require that medical electronics comply with the LVD when it comes into force, "The position for the rest of the community is likely to differ and follow a similar approach to that for EMC. I would therefore suspect that it would be wise for a U.S. manufacturer to ensure that his products meet the LVD on the first of January, 1997, if they do not fully conform to the Medical Devices Directive."

Essential Requirements of the MDD

After the MDD comes into force on June 15, 1998, it will supersede any other directives for medical electronics, and all medical electronics that show compliance with it will be able to market to the member states without restrictions. Article 2 of the MDD states, "member states shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they do not compromise the safety and health of patients, users, and, where applicable, other persons when properly installed, maintained, and used in accordance with their intended purpose."⁵

Annex I of the MDD identifies several essential product requirements that are used to judge its conformity. These requirements pertain to emissions and immunity; electrical and mechanical safety; and conformity assessment (product classification), clinical investigation, and quality standards. The requirements of the EMC Directive are contained in the emissions and immunity section of the MDD, and those of the LVD are in the electrical and mechanical safety section.

To meet the MDD essential requirements for emissions and immunity, manufacturers must undergo product testing in accordance with EN 60601-1-2. In most cases, this testing will need to be carried out by a competent EMC lab. In some cases, the harmonized EMC standard may actually be insufficient for a particular product. A manufacturer should therefore conduct an initial product risk analysis to determine whether the harmonized standard will be sufficient.

To ensure that a product meets MDD requirements for electrical mechanical safety, manufacturers should be compliant with the LVD after January 1, 1997. The safety requirements of this directive are already required for all products shipped to Europe under the International Electrotechnical Commission 601-1 standard. Because verifying that a product complies with essential safety requirements is based on self-certification rather than on the authority of a notified body, it demands expert understanding of these requirements. A notified body under the LVD can, however, issue a technical report verifying this certification if a customer requests this.

Satisfying the MDD requirements for conformity assessment, clinical investigations, and quality standards requires a notified body in many cases.

Conformity Assessment under the MDD

Conformity assessment, explained in Article 11 of the MDD, is an essential part of compliance with the MDD, as this determines the quality standards that must be followed to achieve the CE mark. In this procedure, medical devices are assessed and categorized according to risk factors. Medical electronics can belong to Class I, Class IIa, Class IIb, or Class III.

Class I devices include low-risk, powered devices for patient support or examination. For many of these devices, self-certification will suffice. Devices that are sterile or intended for measurement, however, require the approval of a notified body.

Class IIa devices include potentially hazardous active therapeutic and diagnostic electrical devices as well as low-risk surgically invasive devices for short-term use of up to 30 days. For devices under this classification, a manufacturer's declaration must be reviewed and supported by a notified body. The devices must also undergo a product and quality system review. Different quality options are allowed; a full quality program would require the manufacturer to be registered to EN 46000.

Class IIb devices include potentially hazardous active therapeutic and diagnostic electrical devices that are intended for long-term use of no more than 30 days. These higher-risk devices require that the manufacturer's declaration be reviewed and supported by a notified body and that the manufacturer have a full quality program in place or undergo an EC type examination. (An EC type examination is a test performed by a notified body on a sample of the products.)

Class III devices are those that are intended for direct contact with the heart or central circulatory or nervous systems. Devices in this class require a full quality assurance program and a product design dossier for review and support by a notified body, an EC type examination along with a production quality program, or EC verification by a notified body. (In EC verification, all products or a representative sample of each batch of products are tested by a notified body to ensure that they meet the standards that the sample tested in the EC type examination did.)

Conclusion

Making sure that a medical electronic product intended for the European market is compliant with all applicable regulations can be difficult, especially if the manufacturer does not thoroughly understand the requirements. A strategic plan for complying with the appropriate directives should be devised as early as the product design phase to ensure that costly modifications will not have to be made later. Until the MDD comes into force, following the EMC and, after 1997, the LVD directives will ensure that a medical electronic device will be acceptable for the European market. After the 1998 deadline, following the advice of a notified body recognized under the MDD will be the best way to ensure regulatory compliance for any medical electronic device.

References

1. "Article 8, 18: No. L 169/6 12.7.93," Offic J of the EC, Brussels, European Commission Directorate General, 1989­ 1996.

2. Lohbeck D, and Schonfeld R, "CE Marking: A Midterm Report," Evaluation Eng , 35(7):34­38, 1996.

3. Frier L, "Certification Requirements for World Wide Acceptance of Electro-Medical Devices," Baltimore, MET Laboratories, 1996.

4. Medical Devices Agency Directives Bulletin, Bulletin 15, Broadheath, Altrincham, Cheshire, UK, AMTAC Mediqa, AMTAC Certification Services, 1994­1995.

5. Article 2: No. L 169/6 12.7.93, Offic J
of the EC, Brussels, European Commission Directorate General, 1989­ 1996.

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Roger Smith is vice president of engineering services at Educated Design & Development, Inc. (Raleigh, NC).