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

Class IIb
The manufacturer may choose one of the following conformity assessment routes to demonstrate conformity of the product to the Medical Device Directive:

Annex II,
Annex III and Annex IV,
Annex III and Annex V, or
Annex III and Annex VI.

Requires the intervention of a Notified Body.

Class III
The manufacturer may choose one of the following conformity assessment routes to demonstrate conformity of the product to the Medical Device Directive:

Annex II.
Annex III and Annex I, or
Annex III and Annex V.

Requires the intervention of a Notified Body.

Full Quality Assurance

Class I (Sterile and Measuring), Class IIa, IIb, and III require the intervention of a Notified Body which will be responsible for auditing the manufacturer's quality system in accordance with the ISO 9001, EN 46000, and ISO 13485 standards. The Notified Body will also determine whether or not the product conforms to the requirements of the Medical Device Directive.

The scope of the ISO 9000 series specifies quality system requirements for design, development, production, installation and servicing. The EN 46000 and ISO 13485 standards are based on the ISO 9001 standard and have been specifically developed to address the quality system in relation to the production of medical devices. All elements, requirements, and provisions adopted by the manufacturer for the quality system must be documented in a systematic and orderly manner. This is done in the form of written measures, procedures and instructions. This documentation must make possible a uniform interpretation of the quality programs, quality plans, quality manuals and quality records.

IV. Compliance with the Essential Requirements of the Directive

An important principle in preparing for the CE Marking process is compliance with the essential requirements of the Medical Device Directive. The essential requirements of the Medical Device Directive are contained in Annex I of the Directive. They describe, in a general way, the safety objectives of the Directive.

Compliance with the essential requirements, where applicable, is mandatory.

The essential requirements in Annex I are divided into general requirements and specific requirements with regard to the design, construction and information that must be supplied by the manufacturer.

Issues addressed with regard to design and construction include: chemical, physical and biological properties; infection and microbial contamination; construction and environmental properties; and information supplied by the manufacturer on the label and in the instructions for use.

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