Chapter II, Article 6 · Commission Implementing Regulation (EU) 2020/1207

Contents

Article 6Original intended purpose and monitoring of changes made by the manufacturer of the original single-use device#

1.Reprocessors shall not change the original intended purpose of the single-use device as indicated in its instructions for use.

2.Reprocessors shall establish a monitoring process to verify the following:

(a)that the single-use device is not withdrawn from the market;

(b)that the certificate of conformity of the single-use device has not been suspended, withdrawn or is not subject to restrictions;

(c)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.

Defined terms · 3

Show every defined term

external reprocessor
means the entity reprocessing single-use devices at the request of a health institution;
reprocessing cycle
means a cycle that includes all reprocessing steps applied to a single-use device to ensure that the safety and performance of the reprocessed device is equivalent to that of the original device.
reprocessor
means the health institution and the external reprocessor reprocessing single-use devices;