OEM IVD's and CE requirements

[brandomenon]

My company is looking to add to our product line by entering an agreement with a company to re-label their existing CE marked IVD with our branding. Both devices would then be available in the marketplace. We currently have a couple of self-declared CE marked IVD products (Class II).

How do we make sure all our regulatory bases are covered (i.e. what's the path of least resistance to CE marking the device with our labels on it)? The directive is clear that we are still the 'manufacturer' but does not provide much guidance on technical files or dealing with NB's.

Thanks!

 

[QA-Man]

I have many questions I'd like to ask but I'll start with this: Do you have a notified body? If you do not, you cannot put a CE mark on anything.

If you have a notified body, I would contact them and discuss it with them. CE marks are non-transferable. If the other company has their technical file in order it shouldn't take them long to approve the device for you.

Also, you cannot self-declare a Class II device and devices according to MDD are class IIa or IIb (there is no class II).

 

[brandomenon]

We do have a notified body for the IVD's that are already CE marked (where we are the manufacturer). My job is to find the simplest way to re-label a device with our own branding and get that device CE marked.

 

[brandomenon]

Will we need access to the other company's file, or do we make reference to it?

 

[Roland Cooke]

See this thread: Own Brand Labelling (OBL) Agreement, and the one linked from it.

 

[brandomenon]

Also, you cannot self-declare a Class II device and devices according to MDD are class IIa or IIb (there is no class II).

Ok so I got myself a little mixed-up. I reviewed the tech file for one of our devices. It is not class II (a or b) and is self declared.

Since the IVD device that we are considering for the OEM proposal will also be self declared, what other considerations are there?

The draft "NB-MED/2.5.5/Rec 5" from the thread Roland provided was excellent - thank you!

 

[QA-Man]

Is it class I?

 

[brandomenon]

Yes - it would be the same type of device as the currently CE marked device.

 

[QA-Man]

Looking at MDD 93/42/EEC Annex IX Rule 8: "All implantable devices and long term surgically invasive devices are in Class IIb unless....."

Looking at MDD 93/42/EEC Annex IX Rule 14: "All devices used for contraception or the prevention of the transmission of sexually transmitted diseases are in Class IIb, unless they are implantable or long term invasive devices, in which case they are in Class III"

I would classify an IVD as class III.

 

[Roland Cooke]

IVDs are controlled by the IVD Directive, not the MDD.