It would be difficult to find someone who hasn't heard of the ISO 9000 series quality system standards. These documents clearly delineate 20 common-sense requirements that companies should follow if they want to remain in business. The ISO 9000 series, in addition to being standards for quality management, also define -- and support -- a profitable quality management system.

It's difficult to understand why, in a country like the United States, which is so widely regulated (Food and Drug Administration, Occupational Safety and Health Administration, and Environmental Protection Agency, to name just a few), knowledge of and compliance to the European Union Directives is so painfully lacking, especially when they define the rules that will allow manufacturers of those regulated products to continue to sell them into the European market. There are several potential answers. It could be that we just haven't heard of the requirements because they apply only to products exported to the European Union.

Perhaps the answer is that the need for compliance has not (deliberately or otherwise) been communicated to us. It may be due to other domestic pressures and regulations, coupled with our litigious society. In part, it may be due to lethargy and postponing the inevitable without realizing that time has run out. It is probably a combination of these reasons, along with a healthy dose of other issues.

Whatever the reasons, it's time to actively comply with the directives. Because the United States is not a member of the European Union, it has virtually no input into the decisions of the European Commission or the documents that it enacts. This leaves us, and a majority of countries around the world that export regulated products into the European Union, in a position where we must comply with a set of laws that have been thrust upon us. The example that this article will use to illustrate the directives and the issues associated with them is the Medical Device Directive. Compliance with this directive is less than one year away and not an easy task to accomplish.

Overview of the Medical Device Directive

One of the more important impending requirements that manufacturers of medical devices must meet is the European Union Medical Device Directive. The directive, officially known as 93/42/EEC, is one of the more frustrating mandates to decipher and understand, making compliance more difficult than it has to be. Unfortunately, the MDD was written by the same organization that gave us the 26,911-word treatise known as "The European Economic Community Directive for Export of Duck Eggs"!

The MDD consists of 23 articles, 12 annexes and 18 classification rules, all of which send those who must comply with the requirements scampering through a bureaucratic maze of redundancy. Reading and understanding the Food and Drug Administration's new quality system regulation is child's play compared with any attempts to digest the MDD.

The MDD is intended to harmonize standards that benefit manufacturers, users and patients, and to define the requirements for the clinical testing, design, manufacture, testing/inspection, marketing, installation and service of medical devices sold within the European Union. All medical devices sold within the European Union must conform to this directive by June 1, 1998; however, this date is the end of the phase-in period, which began on January 1, 1995.

MDD overview

The MDD actually specifies three primary provisions for medical devices: the essential requirements, classification rules and conformity routes for assessment.

 Essential requirements -- Minimum essential requirements for the design and manufacture of medical devices ensure the protection of the health and safety of patients, users and third parties. These requirements stipulate that the principles of safety should be integral to the design of the product and that the product should be suitable for its intended purpose. The essential requirements are defined in Annex I of the MDD.

 Classification rules -- The MDD places all medical devices into one of four classes of increasing risk to the patient according to their properties, function and intended purpose. The level of control is proportionate to the level of risk to ensure protection of patient health. Eighteen rules classify medical devices that require understanding and interpretation, as there are no clear-cut categories.

Class I devices are those that pose a low risk to the patient and, except for sterile products or measuring devices, can be self-certified by the manufacturer. Generally speaking, these devices do not enter into contact or interact with the body.

Class IIa devices are of a medium risk that may require assessed quality systems to the ISO 9000/EN46000 standards. These devices are invasive in their interaction with the human body, but the methods of invasion are limited to natural body orifices. The category may also include therapeutic devices used in diagnosis or in wound management.

Class IIb devices are of a medium risk that may require assessed quality systems to the ISO 9000/EN46000 standards; third-party certification is required. They are either partially or totally implantable within the human body, and may modify the biological or chemical composition of body fluids.

Class III devices are of high risk and require design/clinical trial reviews, product certification and an assessed quality system. All third-party product and system certification must be conducted by a European Notified Body (or designee through formal agreement). Generally speaking, these devices affect the functioning of vital organs and/or life-support systems.

Medical device classification may also be affected by the time period in which the device performs its intended function. Three definitions for duration of use apply to the directive: transient (normally intended for continuous use of less than 60 minutes), short-term (normally intended for continuous use of 30 days or less) and long-term (normally intended for continuous use of more than 30 days).

 Conformity routes -- One of the more complex activities facing a medical device manufacturer seeking to comply with the requirements of the MDD is the selection of a conformity assessment route. Manufacturers are given a choice of paths by which they can meet the MDD requirements; the class attributed to the product will determine the route that must be followed. The conformity procedures basically address two stages: design and manufacture.

For design, manufacturers must provide objective evidence of how the device meets the essential requirements. This technical information should be held within a technical file or "design dossier." For manufacture, a documented quality system must be in place to ensure that the devices continue to comply with the essential requirements and are consistent with the information in the technical file.

Routes of conformity assessment are identified in annexes II, III, IV, V, VI, VII and VIII. Many of these annexes contain requirements that the manufacturer's quality system be assessed and be in compliance with the applicable EN46000 series standard, and that those assessments be conducted by a notified body (or through an agreement with another organization) authorized to perform MDD assessments.

Because the classification of the device determines the appropriate conformity assessment route, it is critical that this important step in the overall process be made on an informed basis. A manufacturer would be wise to seek the advice and counsel of a notified body to assist them in this activity.

MDD articles

Twenty-three articles comprise a portion of the MDD that sets the stage of compliance. Basically, this first section of the MDD provides definitions, defines the rules and routes for compliance, describes the classification of medical devices and points the reader to the second section of the document -- the 12 annexes that provide the detail.

Article 1 includes the scope of the document as well as important definitions; it also defines those products to which the directive does not apply. The primary definition in the MDD is for a "medical device" itself, namely "any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purposes of: diagnosis, prevention, monitoring, treatment or alleviation of disease; and      diagnosis, monitoring, treatment or alleviation of or compensation for an    injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means."

Article 2 states that European Union member states are required to take any and all steps to enforce compliance with the MDD.

Article 3 states that all medical devices must meet the (applicable) essential requirements of the directive defined in Annex I. These essential requirements are basically the legal requirements for marketing medical devices into the European Union.

Article 4 says that member states are not to impede placement of medical devices on the market provided those devices bear the CE Mark (which means that the manufacturer has met all conformity assessment procedures defined in Article 11).

Article 5 requires that manufacturers meet the requirements of applicable standards and guidelines (including those for EN46001 or EN46002).

Article 6 defines the assistance of the Committee of Standards and Technical Regulations in the promulgation of the directive.

Article 7 defines the assistance of the Committee on Medical Devices in the promulgation of the directive.

Article 8, known as the Safeguard Clause, provides member states with the authority to restrict or prohibit placement or withdraw devices for failure of the manufacturer to meet the essential requirements, for incorrect application of the standards referenced in Article 5 and/or for shortcomings in the standards themselves.

Article 9 classifies medical devices into classes I, IIa, IIb and III. It also states that in the event of a classification dispute between the manufacturer and the notified body, the decision is to be referred to the competent authority (the organization that accredits the notified body) for resolution.

Article 10 describes the necessary steps that member states and the manufacturer must take in the event of a serious injury or death in which the medical device was involved. This is basically the "recall clause" of the directive and is similar to the requirements of the Medical Device Reporting Regulation (21 CFR 803).

Article 11 defines and describes the conformity-assessment procedures summarized earlier. It also describes conformity requirements for custom-made devices and devices intended for clinical investigations.

For Class I devices (other than those that are custom-made or intended for clinical investigation), the manufacturer may declare that the product complies with the essential requirements of the MDD (Annex VII), prepare technical documentation and affix the CE Mark. The manufacturer (or its authorized representative) must register its activities with the competent authority of the member country in which its registered business is located.

A notified body does not need to be engaged for these activities. The exceptions to this procedure are for Class I devices supplied in a sterile condition or having a measuring function; in such cases, the notified body must examine the manufacturing process with respect to sterility and/or measuring function.

For Class IIa devices (other than those that are custom-made or intended for clinical investigation), two alternatives are available to the manufacturer. The first option is for Full Quality Assurance System assessment (Annex II, except for Section 4); the second option is for the EC Declaration of Conformity (defined in Annex VII), coupled with either the procedure relating to EC Verification (Annex IV), the procedure relating to the EC Declaration of Conformity (Production Quality Assurance, Annex V) or the procedure relating to the EC Declaration of Conformity (Product Quality Assurance, Annex VI).

For Class IIb devices (other than those that are custom-made or intended for clinical investigation), two alternatives also are available to the manufacturer. The first choice is for Full Quality Assurance System assessment (Annex II, except for Section 4); the second option is for the EC Type-Examination (Annex III), coupled with either the procedure relating to EC Verification (Annex IV), the procedure relating to the EC Declaration of Conformity (Production Quality Assurance, Annex V) or the procedure relating to the EC Declaration of Conformity (Product Quality Assurance, Annex VI).

For Class III devices (other than those that are custom-made or intended for clinical investigation), the manufacturer also has one of two options for conformity. The first selection is for a Full Quality Assurance System assessment (Annex II); the second alternative is for the EC Type-Examination (Annex III) coupled with either the procedure relating to EC Verification (Annex IV) or the procedure relating to the EC Declaration of Conformity (Production Quality Assurance, Annex V).

Requirements for custom-made devices are found in Annex VIII; requirements for devices intended for clinical investigation are found in Annex X.

Article 12 defines requirements to be met for assembly or sterilization of devices that bear the CE Mark. Such activities require verification of mutual compatibility, appropriate packaging, and appropriate controls and inspections. Sterilization requires compliance with the procedures in annexes IV, V or VI.

Article 13 provides for a decision of the application of the classification rules defined in Annex IX specific to classification of a device or family of devices.

Article 14 defines the requirements for registration of responsible persons (or designated individuals) who place devices on the market within the European Union.

Article 15 describes the requirements for devices intended for clinical investigations (primarily compliance with Annex VIII) and notification of the competent authorities in the member states in which the investigations are conducted.

Article 16 defines identification and responsibilities of notified bodies.

Article 17 describes the requirements for CE marking (primarily identified in Annex XII), accompanied by the identification number of the notified body responsible for implementation of the procedures defined in annexes II, IV, V and VI.

Article 18 articulates the penalties for wrongly affixing the CE Mark to medical devices.

Article 19 describes the appeal procedures to be followed by a manufacturer of a medical device in the event that its product is restricted or refused placement within the European Union.

Article 20 requires that member states are bound to confidentiality with regard to all information obtained in promulgating the directive.

Article 21 repeals and/or amends several previously ratified directives based on the issuance of 93/42/EEC.

Article 22 describes the implementation and transition periods of the MDD.

Article 23 defines and authorizes the MDD, effective June 14, 1993.

Conclusion

As the reader of (and potential individual who must comply with) the MDD, it should be evident that this document is not one to take to the beach and read between dips in the ocean and the application of sunscreen. The directive is complex and written in a manner that requires the reader to shuffle through its pages in an attempt to determine what must be accomplished to meet the terms and conditions of the document.

We have not even begun to describe the "meat" of the directive, namely the 12 annexes that define the rules for compliance. Part 1 of this article provided the groundwork and outline of the directive; Part 2 will describe the activities and procedures to meet in order to comply with the legislation.

About the author

Les Schnoll is the director of regulated industries for KPMG Quality Registrar. He can be reached at 2800 Two First Union Center, Charlotte, NC  28282, telephone (704) 335-5519.

Schnoll is the author of the upcoming book The CE Mark: Understanding the Medical Device Directive.