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This standard is a technical specification applicable to the quality management systems for the design, development, installation, production and servicing of medical devices. For the purpose of this standard a medical device, as described in the European Medical Directive is:

“… any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the necessary software for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

• Diagnosis, prevention, monitoring, treatment, or alleviation of disease
• Diagnosis, monitoring, treatment, alleviation of or compensation for injury or handicap
• Investigation, replacement or modification of the anatomy or of a physiological process
• Control of conception

And which does not achieve its principle intended action in or on the human body by pharmacological, immunology or metabolic means, but which may be assisted in its function by such means …..”

• ISO 13485 is based on the ISO 9000 process model
• Class 1 devices – Generally require just internal control of production and compilation of a technical file. ISO 9000 satisfies this requirement. The technical file may be viewed by a Competent Authority
• Class 2a devices – Require a quality management system to ISO 9000 + ISO 13485 and a technical file. Needs audit by a Notified Body
• Class 2b devices – Requires a quality management system to ISO 9000 + ISO 13485 and compilation of a technical file to include design. The final step is audit by a Notified Body
• Class 3 devices – Being the highest risk devices, it is necessary to implement a quality management system to ISO 9000 + ISO 13485 and compilation of a designer dossier which is a more detailed Technical File. The final step is audit by a Notified Body
• There are other conformance routes covering Own Brand labeling and System and Procedure Packs
• A risk management process, such as ISO 14971, including hazard analysis and risk control is required
• An Authorized Representative in Europe is required for products produced outside Europe; must have possession of Technical File.
• European distributors often act as an Authorized Representative; independent companies also serve a roll when companies have multiple distributors
• Registration with the Competent Authority of the country in which the product will be made available is a requirement.