Question: Shall procedure pack producer (PPP) obtain certification for the sterilisation activities from a NB as per Art. 22 (3) even if still have valid EC certificate as per Art. 12 (3) extended until May 2024?
We perfectly agree that the procedure packs (PP) shall follow the MDR as of DOA – for all below scenarios:
1. Procedure packs containing exclusively devices CE marked according to the MDR
2. Procedure packs containing both devices which are CE marked according to MDD or according to MDR
3. Procedure packs containing exclusively devices CE marked according to the MDD
But with the valid EC certificate for Article 12 (3) of the MDD for sterilization, shall PPP prepare the statement as per art.22 MDR with indication of EC Certificate valid under art. 12 (3) MDD?
...Or this is mistake of Notified Body that extended the certificate for art. 12 MDD until 2024?
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Katarzyna Chrusciel
Engineer
Cavezzo
Italy
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