Article 6 Original intended purpose and monitoring of changes made by the manufacturer of the original single-use device
United Kingdom
Reprocessors shall not change the original intended purpose of the single-use device as indicated in its instructions for use.
Reprocessors shall establish a monitoring process to verify the following:
that the single-use device is not withdrawn from the market;
that the certificate of conformity of the single-use device has not been suspended, withdrawn or is not subject to restrictions;
the use of the single-use device is not subject to restrictions for safety reasons based on the information referred to in Article 5(3), (b) and (c);
The reprocessors shall also identify any change made by the manufacturer to components, materials, intended purpose or specifications of the single-use device that may have an impact on the reprocessing. Reprocessors shall assess the significance of these changes for the appropriateness of reprocessing. If a change has a detrimental effect on the reprocessed single-use device, reprocessing shall be discontinued or the reprocessing process shall be modified to adapt to the change made to the single-use device.