Class 1 medical device classification
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This document outlines the classification rules for medical devices as defined by the European Medical Device Directive (MDD 93/42/EEC). It discusses four general classifications for medical devices - non-invasive, invasive, active, and special rules - and provides more details on the classification of Class 1 medical devices. Class 1 medical devices are the lowest risk devices, including those that only touch intact skin, store substances for administration, act as a mechanical barrier, are used orally or in body cavities for short periods, or are reusable surgical instruments used transiently.
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Class 1 medical device classification
- 1. Class 1 Medical Device as per MDD 93/42/EEC Mary Roopsy www.i3cglobal.com mrj@i3cglobal.com
- 2. The MDD 93/42/EEC defines the classification rules for the medical devices which depend on the following factors: • The time period for which the device in contact with the person • Is the device invasive or surgically invasive • Is the device non-active implantable or active implantable • Any special rules applicable
- 3. As per MDD, rule 1 to 18 is available for the classification of the medical devices among the general classifications as below: • Non-invasive devices • Invasive devices • Active devices • Special Rules
- 4. For class 1 medicaldevice classificationin Non-invasivedevice Rule 1 states, medical devices either do not touch the body part or just touch the intact skin. Rule 2 states medical device intended for channeling or storing for eventual administration except with the use of blood and connected to an active device is class 1 medical device. Rule 4 states medical devices in contact with the injured skin as mechanical barrier , compression device or absorb exudates are class 1
- 5. Forclass1 medicaldeviceclassificationin invasivedevice Rule 5 states medical devices invasive through body orifice not surgically with the transient use (less than 60 minutes) are class 1 Rule 5 states medical devices invasive only in the oral cavity or in ear canal or nasal cavity with the short term use ( less than 30 days) are class 1 Rule 6 states the reusable surgical instruments that is surgically invasive for transient use is class 1
- 6. For class 1 medicaldevice classificationin active device • Rule 12 states active devices other than therapeutic devices for exchange of energy, for diagnosis, to supply energy, to administer or remove medicines or other substances to or from the body are class 1