NIST GCR 01-815
A Guide to the EU Medical Device Directive

B. International Standards

Where no Harmonized Standards exist, manufacturers are instructed to use standards that emanate from international standards developing organizations such as the ISO and IEC. (See NIST SP 951 A Guide to EU Standards and Conformity Assessment, Page 16.)

C. National Standards

The third best choice of the Directive is the use of European national standards, to be used when no Harmonized Standards or International Standards exist.

The principle of applying standards, therefore, is the following:

Medical Device Harmonized Standards* that have been developed specifically to deal with the essential requirements of the Medical Device Directive provide an assumption of conformity (See NIST SP 951 A Guide to EU Standards and Conformity Assessment, Page 11). In their absence, the manufacturer is entitled to comply by using any appropriate specifications that may demonstrate conformity with the safety objectives, or the essential requirements of the Directive. However, the manufacturer must bear the burden of proof that the use of specifications other than Medical Device Harmonized Standards brings the product into conformance.

Note: Medical Device Harmonized Standards take on the presumption of conformity when they are developed by one of the European Standards Bodies (See NIST SP 951 A Guide to EU Standards and Conformity Assessment, Page 10) and published in the Member States as transformed national standards. They are published in the Official Journal of the European Communities for information only.

Note: In other New Approach Directives, publication in the Official Journal of the European Communities is a condition of presumption of conformity.

VI. Risk Analysis

One of the essential requirements of the Medical Device Directive is that the manufacturer is obliged to conduct a risk assessment (See NIST SP 951 A Guide to EU Standards and Conformity Assessment, Page 25).

The principles that can be used to evaluate risks can be found in European Standard EN 1441, which addresses risk analysis for medical devices (See the list of Harmonized Medical Device Standards*).

The standard EN 1441 consists of nine steps, including:

• Identify the product and describe the intended use;
• Identify characteristics which could affect safety;
• Identify possible hazards;
• Estimate the risk for each hazard for both normal conditions and use in case of failure;
• Determine whether the risk is acceptable;
• Determine whether the risk can be reduced;
• If a risk is reduced (for example by a change in design), determine if other hazards have been generated;
• Evaluate all identified hazards; and
• Determine if the device safety is adequate.
  

 

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