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

Purpose of the Medical Device Directive

The purpose of the Medical Device Directive is to harmonize the regulations and administrative provisions among the member states of the European Economic Area (EEA) (See NIST SP 951 A Guide to EU Standards and Conformity Assessment, Page 1) with regard to the safety, health protection and performance characteristics of medical devices.

Before manufacturers can place the CE Marking (See NIST SP 951 A Guide to EU Standards and Conformity Assessment, Page 17) on their medical devices and legally sell to, or within the EEA, they must be in compliance with the Medical Device Directive.

Basic Steps to Compliance

1. Determining Whether or Not the Product Has To Comply with the Medical Device Directive
2. Classification of the Medical Device
3. Conformity Assessment Routes
4. Compliance to the Essential Requirements of the Directive
5. Harmonized Standards
6. Risk Analysis
7. Technical File
8. Vigilance System
9. EC Verification by Notified Body
10. Authorized Representation and Competent Authority registration
11. CE marking
12. Declaration of Conformity

I. Determining Whether or Not the Product Has To Comply with the Medical Device Directive

The Medical Device Directive applies to medical devices and their accessories. Accessories are considered medical devices in their own right. The manufacturer may use the following definitions (taken directly from the Medical Devices Directive) to help determine whether or not the product is a medical device.

• Medical device: "Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary 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 an injury or handicap,


• investigation, replacement or modification of the anatomy or of a physiological process,


• control of conception,

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