Addressing Procedure pack in the ISO 13485 Manual

If you are the one who makes procedure packs, then you will describe in your ISO 13485 Quality manual what your medical devices are, of which components they consist. In your procedure for production you will describe how you make your procedure packs, are they assembled in the cleanroom, do they need sterilization, how you monitor the traceability of each component (Lot or a serial number of each component), how do you label them, and other relevant things. You need also to prepare a medical device file for them.

For more details, I would need to know what kind of procedure packs you have. 

The following article may be useful:

• How to meet ISO 13485:2016 requirements for medical device files - https://advisera.com/13485academy/blog/2017/06/28/how-to-meet-iso-13485-requirements-for-medical-device-files/

What are obligations of the manufacturers for procedure packs in MDR 2017/745, you can find on the following link:

• EU MDR Article 22 – Systems and procedure packs https://advisera.com/13485academy/mdr/systems-and-procedure-packs/