MEDDEV 2.4/1 – rev. 8 PART 2: GUIDELINES FOR THE CLASSIFICATION OF MEDICAL DEVICES (July 2001)
GENERAL EXPLANATION OF RULES/PRACTICAL ISSUES/EXAMPLES
Rule 1 - Devices that either do not touch the patient or contact intact skin only
General explanation of the rule
This is a fallback rule applying to all devices that are not covered by a more specific rule.
This is a rule that applies in general to devices that come into contact only with intact skin or that do not touch the patient.
All non-invasive devices are in Class I, unless one of the rules set out hereinafter
- Body liquid collection devices intended to be used in such a way that a return flow is
unlikely (e.g. to collect body wastes such as urine collection bottles, ostomy pouches,
incontinence pads or collectors used with wound drainage devices). They may be
connected to the patient by means of catheters and tubing.
- Devices used to immobilize body parts and/or to apply force or compression on them
(e.g. non-sterile dressings used to aid the healing of a sprain, plaster of Paris, cervical
collars, gravity traction devices, compression hosiery).
- Devices intended in general for external patient support (e.g. hospital beds, patient
hoists, walking aids, wheelchairs, stretchers, dental patient chairs).
- Corrective glasses, frames, stethoscopes for diagnosis, eye occlusion plasters, incision
drapes, conductive gels, non-invasive electrodes (electrodes for EEG or ECG), image
- Permanent magnets for removal of ocular debris
Practical issues of classification
Some non-invasive devices are indirectly in contact with the body and can influence internal physiological processes by storing,
channeling or treating blood, other body liquids or liquids which are returned or infused into the body or by generating energy that is
delivered to the body. These must be excluded from the application of this rule and be handled by another rule because of the
hazards inherent in such indirect influenc