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feature article

The Road to CE Marking of Medical Devices

By Nils Bromander

SEMKO (Centre for) Medical Engineering and Physics (Kista, Sweden)

General Requirements

All manufacturers must:

  • Classify the devices manufactured (Annex 9), except for those devices designed for special purposes or intended for clinical investigations (Annex 8).

  • Select and follow the appropriate conformity assessment procedure (Annexes 2–7), based upon the class to which the device belongs (Article 11; see summaries for each class below).

  • Ensure that the device fulfills the essential requirements (Annex 1).

  • Prepare technical documentation (Annex 2, 3, 5, or 7), including a general description of the product, design drawings, the results of the risk analysis, a list of standards applied, test reports, etc. This documentation should enable the assessment of the conformity of the product with the requirements of the directive.

  • Establish a system for reviewing data concerning products placed in the market, and implement appropriate means to take any necessary corrective actions.

  • Notify the authorities of serious accidents and/or narrow escapes from injury attributed to the product.

  • Issue an EC Declaration of Conformity.

  • File the EC Declaration of Conformity and the technical documentation, as well as all decisions, reports, and certificates from notified bodies, in such a way as to make the information available to the national authorities for a period ending no less than five years after the last product has been manufactured.

All products must:

  • Comply with the essential requirements.
  • Be provided with CE marking, except for custom-made devices and devices intended for clinical investigations.

Specific Requirements

Class I Products

The manufacturer must declare that the products concerned meet the provisions of the directive. The CE mark may then be affixed to the device (Annex 7).

The manufacturer or its authorized representative for the marketing of the product must register its activities with the competent authority of the member country in which the registered business is located.

An exception is made to this procedure for devices that are placed on the market in a sterile condition and/or have a measuring function. In such cases, the notified body shall examine the production process with regard to sterility and/or measuring function (Annex 4, 5, or 6).

Figure 1 is a flowchart showing the steps involved in CE marking for Class I devices.

Figure 1. Procedure for Class I products.

Class IIa Products

There are two alternative routes to CE marking for Class IIa devices. In alternative 1, the notified body must accept the manufacturer's total quality system (design, manufacturing, and final inspection) according to Annex 2, except for section 4.

In alternative 2, the manufacturer follows the procedure in Annex 7 (see above). In addition, the notified body examines and accepts each manufactured item/batch according to Annex 4 or accepts the quality system for production and final testing according to Annex 5 or the quality system for products according to Annex 6.

After taking the various administrative measures described in the relevant annex, the manufacturer may affix both the CE mark and the identification number of the notified body to the product. Figure 2 charts the procedure for Class IIa devices.

Figure 2. Procedure for Class IIa products.

Class IIb Products

Like manufacturers of Class IIa devices, manufacturers of Class IIb products may choose between two alternative procedures. In alternative 1, once again, the notified body must accept the manufacturer's total quality system (design, manufacturing, and final inspection) according to Annex 2, except for section 4.

In alternative 2, the notified body must examine and assess the documentation and type-test the product according to Annex 3 and examine and accept each manufactured item/batch according to Annex 4 or accept the quality system for production and final testing according to Annex 5 or the quality system for products according to Annex 6.

After taking the various administrative measures described in the relevant annex, the manufacturer may affix both the CE mark and the identification number of the notified body to the product. Figure 3 spells out the necessary steps for CE marking of Class IIb devices.

Figure 3. Procedure for Class IIb products.

Figure 4. Procedure for Class III products.

Class III Products

For Class III devices, once again, two alternatives are provided. In alternative 1, the notified body must accept the manufacturer's total quality system (design, manufacturing, and final inspection) and examine the design of the product according to Annex 2.

In alternative 2, the notified body must examine and assess the documentation and type-test the product according to Annex 3 and examine and accept each manufactured item/batch according to Annex 4 or accept the quality system for production and final testing according to Annex 5.

After taking the various administrative measures described in the relevant annex, the manufacturer may affix both the CE mark and the identification number of the notified body to the product. Figure 4 illustrates the routes to CE marking for Class III devices.

Back to 1999 Annual Reference Guide Table of Contents