NIST GCR 01-815
A Guide to the EU Medical Device Directive
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means."
- Accessory: "means an article which while not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device."
II. Classification of the medical device
If a medical device is within the scope of the Medical Device Directive, the manufacturer must determine the classification of the device.
The classification of the device will decide the conformity assessment route. In other words, it will determine whether the manufacturer can self certify (See Annex VII of the Directive) or whether he or she needs to prepare for a Third Party audit by a Notified Body (See NIST SP 951 A Guide to EU Standards and Conformity Assessment, Page 20) in accordance with the following Annexes of the Directive:
Annex II EC Declaration of Conformity: Full Quality Assurance System
Annex III EC Type Examination
Annex IV EC Verification (Batch Testing)
Annex V EC Declaration of Conformity: Production Quality Assurance.
Annex VI EC Declaration of Conformity: Product Quality Assurance
Classification rules are based on terms related to duration of contact with the patient, degree of invasiveness and the part of the body affected by the use of the device.
1. Definitions for the classification rules
1. 1. Duration
Transient
Normally intended for continuous use for less than 60 minutes.
Short term
Normally intended for continuous use for more than 60 minutes, but not more than 30 days.
Long term
Normally intended for continuous use for more than 30 days.
Concepts of duration such as transient, short term and long term are defined in terms of continuous use. Continuous use is an uninterrupted actual use for the intended purpose.
Note: For instance, a scalpel may be used on the same patient throughout an operation that may last for several hours. The uninterrupted use for an intended purpose, i.e., cutting tissue, will normally not last for more than a few seconds at a time. Therefore a scalpel is a transient use device.
However, where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device (e.g., replacement of a ureteric catheter), this shall be considered an extension of the continuous use of the device.
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