The requirements in the CS are not conform with the scope laid down in Article 3 b) MDR.
The CS shall establish special rules for the reprocessing process and must not define responsibilities for parties involved (for example Articles 5, 7 and 8). These are basically fixed in the MDR.
According to article 17 MDR reprocessing can be done either by a health institution or by an external reprocessor.
When applying article 17 (3) MDR the health institution is responsible to meet the CS.
On the other hand, when applying article 17 (4) MDR the external reprocessor is responsible to meet the CS.
Article 2 has to be deleted, because these defintions are not necessary.
Article 3 has to be deleted because any contractual rules are not comprised by the scope of Article 3 b) MDR.
In all relevant Articles 4 to 10 and 21 to 25 the words health institution, external reprocessor and reprocessor are superfluous and has to be deleted.
Due to Article 26 the CS enter into force by 26. May 2020. This is not acceptable because the publishing of the CS are scheduled for November 2019. A sufficient transition period is needed to implement the requirements of the CS. This period should be similar to MDR itself but not less than one year.
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