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Unannounced Audits - Commision Recommendation 2013/473/EU Published 25.9.2013

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Thanks, Steve! Will be interesting to see how this will look in real life. I knew that unannounced audits will come, but I did not realize that this might also hit subcontractors/suppliers (though of course it makes perfect sense, come to think about it...). We might have some suppliers that will kick auditors out the door once they state the purpose of their visit and then cancel the contract with us:D


I'm curious as to three things:

1. Frequency. I'd think there would be a risk process involved in setting this. Will we be asked to participate in the risk evaluation?

2. Payment of costs/charges. I don't think our current MDD-NB contract provides for audit days beyond those of the "normal" process. I doubt very much if our NBs (we are about to have two; one for MDD, the other for MD and PPED) are going to want to work for free.

3. Harmonization with US FDA's VARS Program rules.

Sidney Vianna

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There seems to be a bit of an element of putting fear into Medical Device manufacturers, or am I being paranoid?
Steve, thank you very much for the update.

It seems to me that the European Commission is cracking down on the conformity assessment practices because, as we all know, there is significant variation in the conformity assessment practices performed by Notified Bodies and Conformity Assessment Bodies.

Regulatory agencies are under continual societal and governmental scrutiny to manage the risks of their respective supply chains, so, they will continually increase the strictness of the conformity assessment protocols in order to minimize the chances of nonconforming products and systems being allowed into the marketplace.

Unfortunately, there are interested parties in the conformity assessment sector who don't take their responsibilities serious enough and allow substandard products and systems to attain and maintain the certificates that they need to trade. Even more unfortunate is the fact that a percentage of the manufacturers deliberately seek and retain incompetent auditors, conformity assessment and notified bodies because they represent an easier and cheaper path to the approvals they need.

I would think that the responsible medical device manufacturers should not worry too much. They might see more strict audits and an oversight process a little more expensive. Conversely, the people who like to shortcut the processes should worry.


There seems to be a bit of an element of putting fear into Medical Device manufacturers
I don't see "fear". It seems like a straightforward analysis to me. I'd quibble as to whether parts of it are analyzed correctly, but that's a separate matter.

It also doesn't address practicality, which I see as significant.

If the unannounced audit team shows up on a day when all three of our conference rooms are tied up...a common state..., or we have a customer audit (or hypothetically, FDA inspection) underway, and/or more than one critical audit response person is sick/on vacation/otherwise not available, the audit will be inefficient at best.

Of course, such excuses would be offered by a company that wished to duck the unannounced audit, so they cannot be accepted at face value. There will need to be procedures for how to deal with such practicalities, though, because inevitably they will arise.


When I indicated ?fear?, it was not related to the published Regulation and Recommendations (I agree the need for ?best practices?), it was just to do with extra emphasis this particular NB is making (i.e. you?ll be fine with us as your NB) e.g.:

???increase certification costs over a three-year period by between 20% and 50%.?

???all MEDDEV and NB MED guidance is strictly followed.?

??..justifications for all statements?

?Manufacturers urgently need written procedures for managing unannounced audits?

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