EU MDR 2017/745 Article 22.3

[StepPCHen]

Hello everyone,

I have a question on Procedure Packs and the TD / classification / route to conformity.

Under MDD we have always been claiming compliance to Art. 12 on the TD for procedure packs, Class Is.

During our MDR Audit the auditor wrote a NC on my TD / DoC as i had stated
"procedure packs are classified through EU MDR 2017/745 rule 1, Art.22.3 and Annex IX". I also called Art 22.3 on the DoC.

The auditor raised the point " but there is no statement that for those procedure packs, sterilization has been carried out in accordance with the manufacturer's instructions."

I do not have this statement and would be shocked if every procedure pack producer had it. I have requested it from each manufacturer of the CE marked devices inside the procedure pack but no manufacturer will provide.

I have an audit in 2 weeks to close the NCs and have become stuck on this. I tried to justify it during the audit saying we check the labelling of each device to ensure they do not state do not resterilise, and the fact that we have done this for 20+ years with no complaints, recalls etc. but the auditor was having none of it.

Can anyone help me here please?

 

[Ronen E]

I'm not sure what exactly the issue is.
I'm trying to read between the lines, and this is the sum of what I get:
You buy finished, sterilised devices from various manufacturers (maybe some non-sterile ones as well), assemble a procedure pack, and re-sterilise it...? The auditor's concern is that some of the pack's components undergo repeated sterilisation, and you have no evidence on record that this does not cause any deterioration in any of the (pre)sterilised devices. Your sterile devices manufacturers are unwilling to provide evidence to that extent (maybe they don't have it).
Is that an accurate reading of the situation?

Generally speaking, if the devices in the pack are sterilised (regadless of whether they were previously sterilised), someone - either the original manufacturer or the steriliser (you) - needs to show that the device will stay within spec following the sterilisation, as performed prior to placing on the market. If they didn't do it then you most likely have to do it.

 

[kenbarlow]

The regulatory responsibility for sterilisation lies with the kit packers. The manufacturer of the non-sterile devices should ensure that certain conditions are met, and share sterilsation parameters.

These conditions include having a written agreement between the manufacturer and the kit packer, providing instructions for maintaining proper records, and acknowledging that the device is non-sterile and is being shipped for further processing.

 

[StepPCHen]

I'm not sure what exactly the issue is.
I'm trying to read between the lines, and this is the sum of what I get:
You buy finished, sterilised devices from various manufacturers (maybe some non-sterile ones as well), assemble a procedure pack, and re-sterilise it...? The auditor's concern is that some of the pack's components undergo repeated sterilisation, and you have no evidence on record that this does not cause any deterioration in any of the (pre)sterilised devices. Your sterile devices manufacturers are unwilling to provide evidence to that extent (maybe they don't have it).
Is that an accurate reading of the situation?

Generally speaking, if the devices in the pack are sterilised (regadless of whether they were previously sterilised), someone - either the original manufacturer or the steriliser (you) - needs to show that the device will stay within spec following the sterilisation, as performed prior to placing on the market. If they didn't do it then you most likely have to do it.

Hi Ronen,

We purchase non-sterile devices, include them in a procedure pack and sterilise using our own EO cycle. We do not have statement to say that sterilisation has been carried out in accordance with the manufacturers instructions.

I had contacted the manufacturers of the device and they are reluctant to put anything in writing to me to say that our EO cycle is suitable.

 

[Ronen E]

Hi Ronen,

We purchase non-sterile devices, include them in a procedure pack and sterilise using our own EO cycle. We do not have statement to say that sterilisation has been carried out in accordance with the manufacturers instructions.

I had contacted the manufacturers of the device and they are reluctant to put anything in writing to me to say that our EO cycle is suitable.

"In accordance with the manufacturer's instructions" has 2 aspects:
1. Making sure that the proposed cycle is actually effective in sterilising the device.
2. Making sure that the proposed cycle does not deteriorate the device performance to a spec breach.

I understand that the manufacturers are unwilling to provide assurance of any of the above. In other words, they are saying "we won't provide instructions, because we don't/can't endorse your cycle, and the reason is we never assessed/validated it." The problem is not "lack of instructions", but lack of confidence in the cycle capability and safety (from device spec perspective). Indirectly, the auditor is raising the concern that the process is not fully validated, hence the pack safety and effectiveness are not guaranteed.

Aspect 1 above has probably been addressed in your sterilisation validation. So far so good (I assume).
Aspect 2 still needs to be established. I get the impression that the OEM won't do it; so it falls back to you.

 

[WAQAR-QMS]

In your case, it is definately a validation study requirements for sterilization from manufacturer that they need to put on IFU after validation.
As the original manufacturer should give it to you, but sometimes they dont know about stuff.
You can guide them to complete this validation for sterilization.
You can use third party or do it in house, you can also conduct it on manufacturer's behalf by getting few things in line from them and there could be few other ways.
Although it depends on your conformity route if you are claiming CE based on Sterilization or contract manufacturing of product.