Medical Device re-classification and marketing

[jkc3usc]

My company has decided to reclassify a device from class 1 to class 2. This was a decision made by us and no regulatory authority. My question is as we submit for the reclassification can we continue to market the device? Nothing about the device is changing besides the classification. Can we keep the marketing literature all the same until we get reclassified.

Anyone have any experience or thoughts on this.

Thanks

 

[Marcelo]

Totally depends on the regulatory system. You may need to perform additional conformity assessment activities or even re-register the device.

 

[jkc3usc]

Again nothing on the device is changing, no specs, nothing in design. Since the device is currently on the market we want to continue to market and sell it as a class 1. Make no changes to any material of documents.

I guess I'm confused as to why I would reassess conformity if nothing has changed and also re register now? Wouldn't the new conformity assessment and re registering happen if needed once the approval for the reclassification happens?

thanks for your help

 

[Al Rosen]

Did the intended use change?

 

[yodon]

As @Marcelo Antunes points out, the clearance pathway may be substantially different. For example, many Class I devices are exempt from Design Controls in the US. That's generally not the case for Class II devices. You would then have to prepare the full Design History File.

 

[Ronen E]

My company has decided to reclassify a device from class 1 to class 2. This was a decision made by us and no regulatory authority.

I'm totally baffled by these statements.
First, why would you do something like that?
Second, when you talk about a "submission", are you referring to an application (to who?) to reclassify your own device? Anything else?
What you need to and can do totally depends on why you think it should be upclassified and on the formal regulatory path you take.

 

[jkc3usc]

Nothing is changing. Intended use stays the same. Again this is not my decision to reclassify. I am just wondering as they submit documents to reclassify I want to make sure we can still market and sell the device as a class 1.

 

[Rincewind]

Hello,

other than the fact that I am also very curious why anyone would willingly let their device get higher classified than necessary, it would help to know about what Regulatory System you are talking.

 

[yodon]

It's a bit unclear to me when you say 'market ... as Class 1.' Classification is for regulatory clearance. I'm not aware of any particulars on sales or marketing based on device class. I can't imagine, though, how you would be able to market 2 identical devices of different classifications.

@Rincewind - I had a client once who purposefully chose a higher class than was required. This was to make the path more difficult for competitors who wanted to use their device as a predicate. All I could say was "hmm..."

 

[Ed Panek]

Claims are staying the same? Is this a prestige issue or a marketing issue?