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 October 1997 Article

The CE Mark:
Medical Device Directive

Part II

by Les Schnoll

In the September issue of Quality Digest, Part 1 of this article provided a general overview of the medical device directive and described the 23 articles that form the basis for the MDD. Part 2 provides a summation of the MDD's 12 annexes; they define the requirements that must be met by manufacturers of medical devices that desire to market their product in the European Union after June 1, 1998.

The MDD annexes

Twelve annexes comprise this section of the MDD -- they define the compliance requirements. The annexes provide the rules, requirements and assessment routes companies must follow. The annexes are complex and wordy, and do not describe a clear path to reach the finish line -- CE marking of the medical device. The following attempts to clarify the annexes:

Annex I: The Essential Requirements

This is the most important section of the MDD because the essential requirements are the legal requirements that must be met by the end of the transition period (June 1, 1998). These requirements divide into six general requirements and eight design and construction requirements.

Medical Device

Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, intended by the manufacturer to be used for human beings for the purposes of:  diagnosis, prevention, monitoring, treat-ment or alleviation of disease diagnosis, monitoring, treatment or alleviation of or compensation for any injury or handicapinvestigation, replacement or modification of the anatomy or of a physiological processcontrol 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.


  General requirements: The general requirements of Annex I state that:

* The devices must be designed and manufactured in such a way that, when used under the conditions and purposes intended, they will not compromise the health or safety of patients, users or other personnel.

* Safety principles must be utilized for the design and construction, and they should include state-of-the-art technologies.

* The devices must meet all claimed performance criteria.

* The devices must continue to function as intended, without compromising safety or health, when subjected to normal conditions of use.

* The devices must not be adversely affected during defined transport and storage conditions.

* Any undesirable side effects must constitute an acceptable risk when weighed against intended performance.

  Design and construction requirements: These detailed requirements of Annex I define a variety of provisions to be met (as applicable), including:

* Chemical, physical and biological properties

* Infection and microbial contamination

* Construction and environmental properties

* Properties for devices with a measuring function

* Protection against radiation

* Protection against electrical, mechanical, thermal risks, energy supplies or energy substances

* Labeling requirements and instructions for use

* If applicable, demonstration of conformance with essential requirements based on clinical data

Annex II: EC Declaration of Conformity
(Full quality assurance system)

Under this conformity assessment route, once the manufacturer has obtained full quality system registration (including the applicable EN46000 standard), it is entitled to self-declare. This is the most common conformity route used and makes the most sense for those organizations that have registered quality systems. Specifics of Annex II include:

  The manufacturer's quality system must be registered to the applicable ISO 9000 and EN46000 standards, and be subject to routine surveillance assessments. This includes an application for assessment of the quality system to/by a notified body and fulfilling an obligation to notify the competent authorities of any instance of serious injury or death from any of its medical devices. The application must include an adequate description of the manufacturer's quality objectives, business organization, procedures for monitoring and verifying product design, inspection and testing techniques during the manufacturing stage, and final release/approval criteria.

  The manufacturer must inform the notified body that approved the quality system of any planned substantial changes to its quality system.

  The manufacturer must declare its conformity to the MDD and affix the CE Mark in compliance with Article 17 and Annex XII.

  For Class III products, the manu-facturer's technical files/design dossiers must be examined by the notified body to determine compliance with the essential requirements. Changes to the design must be approved by the notified body.

  The manufacturer is required to maintain its declaration of conformity for at least five years after the last product has been manufactured.

Annex III: EC Type-Examination

This conformity assessment route requires the notified body to test and evaluate a representative sample of the device to ensure that the device fully complies with the MDD's applicable requirements and the appropriate technical standards. When the Annex III route is used, it is in conjunction with the procedures defined in Annex IV or Annex V.

Annex IV: EC Verification

The EC verification conformity assessment route requires the manufacturer of the medical device (or its authorized agent) to declare that the product complies with all appropriate MDD requirements and applicable technical specifications. Compliance is based on examinations and tests performed by the notified body. The notified body may, at its discretion, evaluate 100 percent of the devices or use rational statistical sampling methods. If statistical (batch) sampling is utilized, random samples must be taken from each batch or lot manufactured.

If the batch is accepted, all products in the batch may be placed on the market (except those in the sample that failed); if the batch is rejected, the notified body must take appropriate measures to prevent the batch from being placed on the market. If there is a trend of frequent batch rejection, the notified body may ultimately suspend the statistical verification process and revert to 100-percent examination and testing.

Sampling and statistical control of product is based on attribute testing, requiring a sampling system that ensures a limited quality corresponding to a probability of acceptance of 5 percent, with a nonconformity percentage of between 3 percent and 7 percent.

Under this assessment process, the manufacturer must obtain a production-quality assurance registration (production and final testing) in accordance with the appropriate EN46000 standard. Compliance with Annex V must be coupled with the procedures defined in either Annex III or Annex VII (depending upon product classification).

Annex VI: EC Declaration of Conformity (Product quality assurance

Under this assessment process, the manufacturer must obtain a product-quality assurance registration (final testing only) in accordance with the appropriate EN46000 standard. Compliance with Annex V must be coupled with the procedures defined in either Annex III or Annex VII (depending upon product classification.

Annex VII: EC Declaration of Conformity

Compliance with this assessment route requires that the manufacturer of the medical device prepare the appropriate technical documentation to demonstrate full compliance with the requirements of the directive and associated technical standards. The technical documentation should include:

  A general description of the product

  Design drawings, diagrams, schematics

  Product descriptions and explanations

  Results of risk analysis

  A listing of applicable standards

  A description of the sterilization process (sterile products only)

  Results of design calculations and inspections

  Test and inspection reports (and clinical data, if applicable) to support compliance with the MDD

  Labeling and instructions for use


The manufacturer must also institute and maintain a systematic procedure for review of devices in the postproduction phase and must implement appropriate means to apply any necessary corrective actions based on the review and in association with risks related to the product.

Annex VIII: Statement Concerning
Devices for Special Purposes

The processes and procedures defined in Annex VIII apply to custom-made devices or devices designed for clinical investigation. The manufacturer must provide specific documentation relative to the intended use of the product.

For custom-made devices, this information includes:

  Product identification information and data

  A statement declaring that the device is intended for use by a specific patient, as well as the identification of the patient

  The name of the medical practitioner or authorized individual associated with the device

  A listing of features of the device specified in the prescription

  A statement that the device conforms to the essential requirements in Annex I and, where applicable, identification of any essential requirements that have not been met

For devices intended for clinical investigation, this section includes similar information, but is more explicitly defined in Annex X.

Annex IX: Classification Criteria

This portion of the MDD includes three general sections: definitions, procedures for implementing rules and the classification rules themselves. Several definitions applicable to device classification are those for duration (transient, short-term, long-term) and device types (invasive device, surgically invasive device, implantable device, active medical device, etc.).

The classification section is rather vague and takes some skill to properly classify the device. The latest revision of the MDD includes a supplement on classification rules that is more explicit, includes several examples and attempts to streamline and simplify the process.

Annex X: Clinical Evaluation

As mentioned earlier, this section provides details on requirements pertinent to devices intended for clinical investigation. These mandates include compilation of data, statements of confidentiality, and documentation of:

  Product identification information and data

  Clinical investigation plan, including the purpose, grounds, scope and number of devices

  The names of the medical practitioners and/or authorized individuals associated with the investigation

  The identification of the institution responsible for the investigation

  The location, commencement dates and scheduled duration of the investigation

  A statement that the investigation will be performed in accordance with the ethical requirements defined in the Helsinki Declaration

  A statement that the device conforms to the essential requirements in Annex I and that every precaution has been taken to protect the health and safety of the  patients

Annex XI: Criteria to Be Met for the Designation of Notified Bodies

This section of the MDD defines the selection criteria, conduct and responsibilities of those organizations designated as notified bodies. Notified bodies must be accredited by competent authorities.

Annex XII: CE Marking of Conformity

This requirement defines the physical dimensions and appearance of the CE Mark.


We have completed a crash course in MDD 101, and the reader should have a basic understanding of the requirements of this specific European Union Directive. Believe it or not, there are other directives that are more ambiguous and include many more requirements than the MDD; unfortunately, the same need for clarity exists in all of the European Union Directives. Anyone who wishes to have a deeper knowledge of the MDD or any of the other directives should contact a notified body for a more thorough description of the requirements and nuances.


About the author

Les Schnoll is the director of regulated industries for KPMG Quality Registrar, telephone (704) 335-5519. He is also the author of the book, The CE Mark: Understanding the Medical Device Directive, available this fall from Paton Press. Call (916) 342-5480.


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