CLASS 1 MEDICAL DEVICE

These devices are subject to general controls which are those controls that are sufficient to provide reasonable assurance of the safety and effectiveness of the device or the device is not life-supporting or life-sustaining and does not present a reasonable source of injury through normal usage. Devices in this category include tongue depressors, bedpans, and other similar types of common equipment Medical Device Classification .

CE marking of Class I devices meets the 93/42 EEC Medical Device Directives, Annexes VII and I. To this end, the following requirements should be met:

• Technical File for each family of devices should be prepared. This file should contain legal information, documentation, manufacturing process and performance of the product to show its effectiveness and safety. It includes the product Risk Analysis according to the EN 14971 harmonized European Standard, material safety data sheets, biocompatibility of materials, hygiene and sterility tests, manufacturing processes control procedures, operation manual/instructions, and any relevant documentation, as required by Exhibit I “Essential Requirements” of MDD, including clinical and medical support information. According to the type of device, some of these requirements may not apply.
• Choose Conformity Assessment Route: refer the flow chart below.
• Declaration of Conformity.
• Ensure the device is a Class I medical device.
• Vigilance and Post Market Surveillance. (affix CE marking & market the products)
• Appoint an Authorized Representative. (register with the Competent Authority)

Criteria for determining devices with measuring function.

The following criteria, if fulfilled together, indicate that a device has a measuring function:

1. A) The device is intended by the manufacturer to measure: - quantitatively a physiological or anatomical parameter, or - a quantity or a qualifiable characteristic of energy or of substances delivered to or removed from the human body
2. B) The result of the measurement - is displayed in legal units or other acceptable units within the meaning of Directive 80/181/EEC or - is compared to at least one point of reference indicated in legal units or other acceptable units in compliance with the pre-mentioned Directive
3. C) The intended purpose implies accuracy, claimed explicitly or implicitly

Note 1: The expression "claimed implicitly" covers cases where the user, on the basis of the designation of the device or of its accompanying documents, or on the basis of the common use is entitled to expect accuracy (examples: a device designated with the use of the suffix "-meter" or a device where the accuracy of the measurement has an impact on the diagnosis or therapy of the patient).

Note 2: Measuring activities during the manufacturing process including those for calibration purposes are not covered by this recommendation and do not imply a measuring function of the manufactured device.

Note 3: For the following examples, it is assumed that the relevant classification rules permit classification in Class I, provided that relevant criteria are met.

Examples for Class I devices WITH a measuring function: * non-active device for measuring body temperature, * pacifier which includes a non-active temperature display, * device for indicating that a body temperature is above or below a specified value, * non-active non-invasive device for measuring blood pressure, * non-active device for measuring intra-occular pressure, * device for measuring volume or flow of liquid or gases delivered to or removed from the human body (including any container with a graduation scale or with a single point graduation) Examples for Class I devices WITHOUT a measuring function: * patch for indicating trends in body temperature (where criteria B is not met), * device for the delivery of liquid to the human body (e.g. medicine spoons, cups, droppers, without graduation or scale), * device for displaying trends of physiological parameters (e.g. urine drainage bags without graduation or scale, callipers for obesity), * eye-test charts

Class I devices with a measuring function and Class I Sterile Devices must comply with all the requirements for Class I devices. Additionally the manufacturer must:

• establish and maintain the relevant procedures of a Medical Quality Management System (QMS)
• contract a Notified Body who will audit the Quality Management System and Technical Files

These requirements shall be limited to the aspects of manufacture concerned with the conformity of the products with the metrological requirements

Class I Medical Devices: Conformity Assessment Routes

1. The manufacturer is responsible for ensuring that his product complies with all the relevant Essential Requirements of the Directive and must draw up a written statement to this effect (self-declaration).
2. Class I Medical Device without a measuring function and supplied in non-sterile condition does NOT require the involvement of a Notified Body. Conformity to the International and European Standard EN ISO 13485 is voluntary.
3. Manufacturers of sterile products and devices with a measuring function must apply to a Notified Body for certification of the aspects of manufacture relating to sterility or metrology.

Once the manufacturer is satisfied that his products meet all the relevant Essential Requirements, the manufacturer, or his European Authorized Representative if the manufacturer is located outside of EEA, must register with the Competent Authority (CA). He may then affix the CE marking on his products and place them on the EEA market.