What do you have to put in place for Sterile Procedure Packs? MDD Article 12

[ISO 13485 - Medical]

to meet article 12 of the MDD, what do you have to put in place for Sterile Procedure Packs??

Thanks in Advance

 

[Ronen E]

to meet article 12 of the MDD, what do you have to put in place for Sterile Procedure Packs??

Thanks in Advance

From MDD Article 12 (emphasis added):

3. Any natural or legal person who sterilises, for the purpose of placing on the market, systems or procedure packs referred to in paragraph 2 or other CE-marked medical devices designed by their manufacturers to be sterilised before use, shall, at his choice, follow one of the procedures referred to in Annex II or V. The application of the abovementioned Annexes and the intervention of the notified body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged. The person shall draw up a declaration stating that sterilisation has been carried out in accordance with the manufacturer's instructions.

This is on top of any requirements applicable to procedure packs in general, as detailed in sections 2 & 4, Article 12.