Old products new class - Dental Devices - Choosing tests

#1
We have some instruments that have been on the market for decades that were sold as Class I devices thinking that they fell under Rule 5 surgically invasive, transient, reusable. But I guess there was another part that said reusable did not mean anything that could be connected to power. So in effect, drill bits (the end that gets attached to a handpiece) become Class IIa according to the Notified Body (and the MEDDEV though why couldn't they have just listed that upfront in the rules). We are not making the part with the electrical connection.

Even if that is right, we do not have any testing done to Technical Standards, but we have decades of actual clinical use (though not necessarily documented because the instrument isn't really the important thing; the implant is). I've rebuilt a technical file, design history file, but I am just getting rejection to my CAP because I haven't addressed all the gaps (with not explanation of why not). Also basically stated that they'll reject it if the plan gets rejected two more times. So I want to avoid the rejection and do the plan right.

These are the standards listed.
EN 1639:2009 Dentistry — Medical devices for dentistry — Instruments
EN ISO 1797:2017 Dentistry — Shanks for rotary and oscillating instruments
EN ISO 8325:2004 Dentistry — Test methods for rotary instruments
EN ISO 13504:2012 Dentistry — General requirements for instruments and related accessories used in dental implant placement and treatment

I've read through them and just floored at how much testing they put in there, none of which has any sort of acceptance criteria. So how would I go about choosing tests? And would I be able to claim partial compliance? Just seems daunting to have something that has been in use for decades and having to need to do all this (though yes, it should have been done decades ago). Would a CAP as "go through the standards listed and identify tests that would be performed" be suitable as a plan only or would it be expected that the actual tests be listed? Any insight, tips, advise appreciated.
 
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#2
I do expect that you'll have to identify and address all the gaps. The whole idea behind a conformance assessment is to confirm you have met all the applicable requirements. You can't just keep throwing something against the wall to see if it sticks, you need to address all the applicable requirements. (Well, you do have the choice of getting out of the market - Canada saw this when they required MDSAP.) The focus is on safety and effectiveness so the NB *may* accept historical data and a risk assessment showing minimal risk in lieu of testing but they tend to draw a pretty hard line. I'm not familiar with those standards or how compliance is normally demonstrated. You might check with an accredited test lab to see if they can test to those standards. May be costly but using an accredited lab to get test results is usually a very acceptable path forward.

You're not alone. I think we'll see more of this, especially in the IVD market where a LOT of IVDs will be up-classified. I realize that doesn't help you but recognize you're not being picked on.

The alleged "threat" by the NB of three strikes and you're out seems harsh. I know they're under a lot of strain (more work, fewer NBs, etc.) so I can understand them not wanting to have repeated unproductive review cycles.
 
#3
Thanks for the response. Working through them now. Will see what happens. I wonder if they can provide evidence of this three strikes anywhere though.
 
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