Non-compliance policy for the type approval process

Effective date:

The evaluation of devices will be conducted until complete, at which time an approval will be issued provided that no non-compliances were identified. In the event that a non-compliance is identified, the evaluation will continue until no more than five individual non-compliances are found or until no further testing is deemed practical, at which time a non-compliance notice will be sent. It will then be the responsibility of the applicant to correct all identified non-compliances, ensure that the device meets all applicable requirements and supply corrected device samples for evaluation within the specified deadlines. It should be noted that the evaluation may stop before five individual non-compliances are found, depending on their severity.

In the event that further non-compliances are identified (cumulated in the same fashion as above), another non-compliance notice will be sent. After the issuance of a second non-compliance notice, any further non-compliances will result in the closure of the project and no approval will be issued.

A non-compliance is defined as the failure to meet a legal metrological requirement as specified in the applicable regulations/specifications, or an interpretation of those requirements as detailed in any applicable evaluation manual, procedure or document.

This non-compliance policy will be applied to projects whose applications are received on or after .

The following disclaimer will also appear on the non-compliance notice sent to applicants:

Considering the number of non-compliances quoted above, we did not complete the evaluation of your device. Consequently, other non-compliances could remain non-declared at this moment. Taking into account that the responsibility rests with the applicant to make sure that the device meets all the relevant requirements in the approval of the device, we recommend that you not only correct the non-compliances identified above, but also ensure that the device meets all the requirements, thus preventing any potential additional non-compliances. Please see our policy concerning the management of non-compliances, which was outlined on the acknowledgement letter issued at the time that your project was opened.

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