Expiry and re-certification of ISO13485

[Schelte P]

Hi all,

first off, big fan of this community. Over the years I've gained so much tips and insight from like-minded people here. Let's keep each other informed on this forum.

I have an issue, on which I need your experience. I work in a small medical device company, developing class IIa active devices for MR imaging. We have been certified since 2021. Our three year 13485 certificate will expire April 2024. For this reason, our NOBO said we should aim for Oct/Nov this year for our next audit. In this way, any major NC that might come up, can be resolved before the expiry date, resulting in extension of the certificate. Thus far, this sounds logical.

The issue is that we want to bring our first product to market Q2 2024. In practice this means we're polishing the device, the tech file and all things related to the MDR, in order to have ourselves audited and approved according to Annex IX of the MDR in Q1 2024.

It would be highly inconvenient and expensive to have an 13485 audit in Q4 2023 and a seperate audit for MDR / CE in Q1 2024 (with subsequent audits in follow up years...). That's why I'm wondering whether it would be practical to plan the total audit in Q1 2024, with the risk of having our certificate expire. Since the certificate is not directly related to regulatory requirements, and we don't have any products yet, I don't think it might have impact... but I'm not sure.

All in all it comes down to unfortunate timing and the risk of having no certificate temporarily. Obviously, I've planned a meeting with our NOBO for this, but I'd like to hear your 2 cents in this. Any of you have any experience in this? Should I plan the combined audit, with the risk of temporary expiry of certificate?

Kind regards, SP

 

[Sidney Vianna]

Their proposal for an early re-certification audit is because of shortage of resources in their end, and the excuse of potential major non-conformities is just that: an excuse. What is the performance of the system history? Have you had any major NC to date? Do what makes sense for you, not them.

 

[Ed Panek]

Something to consider (Not sure if your NB is in this status)

From 2017 to recently NBs have been preparing for the MDR deadline. So, they hired tons of new technical well paid people to staff their review teams to meet the incoming deadline. Then just recently most of that work has been spread out to meet new 2027 and 2028 deadlines.

You are the CEO or on the board of that NB and look at revenue and see a problem. How can I pay for these high salaries if my invoicing just got split into 1/4 or 1/5 annually of what it was?

Answer: bring other revenue from next year into 2023 as much as possible. Audits, MDR pre work, etc.

The above is just my opinion and not supported by any evidence other than my own NB behavior within 72 hours of the MDR news.

 

[Schelte P]

Thanks for your response. While our company only exists for four years, no major non-conformities were found in external audits during this time. There's no reason this will happen in the next one either (though...since every new auditor has his / her own style, you never know....and somehow auditors change every year).

I'll look into it, but your feedback is appreciated.

S