Technical Manual

Technical Manual TOF-Watch, TOF-Watch S and TOF-Watch SX

a. Establishing standards

The new directive encompasses all medical devices from syringes and blood bags to drug delivery systems and monitoring equipment and classifies devices into groups according to the "risk" to the patient involved with any potential failure of the device. Class I is the lowest category and is for the least risk carrying devices with non-sterile, non-measuring functions, and Class III covers the highest risk categories with complex functions such as drug delivery systems.

b. Third party assessors

Although some devices in Class I are approved and awarded the CE mark on the responsibility of the manufacturer, devices covering more critical areas have a more rigorous approval procedure, compliance is considerably more demanding and requires external validation. All third party assessors, called 'Notified Bodies', must adhere to regulations specified in the directive for which they are appointed and can only be appointed to such a position after gaining approval from their governments under the directive. A Notified Body must be a registered company within the EEA and gain approval from its own government to become a Notified Body.

A Notified Body must be independent and have the expertise, impartiality and integrity to do the job required of it. The directives lay down stringent criteria for the appointment of these bodies, and for their regular inspection by their governments.

Manufacturers can gain third party approval from any of the Notified Bodies, and once established, a Notified Body can operate anywhere in the world.

Where a notified body is involved in the production control phase according to the applicable directives, its identification number most follow the CE marking. The manufacturer or the authorised representative established in the Community affixes the identification number, under the responsibility of the notified body.

c. A transparent system

These new directives cover all aspects of the device from gaining pre-market approval to inuse monitoring. There is even incident monitoring with requirements placed on manufacturers to report incidents associated with fault or failure of a device which could cause, or did cause, serious injury or death. Such an incident is required to be reported to the government of the country in which it occurred.

It is anticipated that these directives will offer an open and transparent system of approval and monitoring of medical devices, and should help to ensure that standards are maintained throughout Europe, regardless of the country or area of use.

3. Declarations of conformity

Declaration of Conformity

The manufacturer or authorised representative established within the Community must draw up an EC declaration of conformity as part of the conformity assessment procedure provided for in the New Approaches Directives.

The EC Declaration of Conformity should contain all relevant information to identify the

Directives according to which it is issued, as well as the manufacturer, the authorised representative, the notified body if applicable, the product, and where appropriate a reference to harmonized standards or other normative documents.

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