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!

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).

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.

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

See this thread: Own Brand Labelling (OBL) Agreement (http://elsmar.com/Forums/showthread.php?t=26417), and the one linked from it.

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


:confused: 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!

Is it class I?

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

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.

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

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

I thought an IVD was an inta vas device (the male version of an IUD) not an in vitro diagnostic device (which I thought was IVDD). That's why I brought up the MDD rules on implantable devices and contraception.

Classifications are completely different when it comes to in vitro diagnostic devices. They have a List A & List B system. So please disregard my posts regarding the class of the device in question.

If we put together the documentation suggested for Notified Body review of an Own Brand Labeled device, should that be enough for a self-declared device?

Since we have a couple of CE marked IVD's already, our procedures are in place for Vigilance and Post Market Surveillance, labeling and display of the CE marking, preparation of Declaration of Conformity, process for identifying significant changes, registration with Competent Authorities, and process for selection and control of the original manufacturer.

I'm also wondering if anyone has any personal experience with OEM with respect to an Authorized Representative? Has anyone experience problems because they have a different AR than the original manufacturer? Any other advice?

Follow the following steps to CE-mark your OBL IVD;
1. to compile a TF (have an agreement with the supplier to have access to its TF)
2. to comply with ISO 13485 (certified by a NB)
3. to make a DoC
4. to assign a EU rep (if you are outside of EU)
5. to comply with the language requirements of the target markets
6. to let your EU rep notify its national competent authority to place the IVD on the EU markets
7. to launch your IVD.

You are done!

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!
The manufacturer places the CE Mark, that would be them not you. If you rebrand it sell it as yours you are also responsible from a legal perspective so verify their technical file or documentation supports placement of the CE Mark per the IVD Directive Essential Requirements (EMC testing has been done to IEC 61326, safety testing completed to IEC 61010-1, risk analysis per 14971, etc). It can be self-certified if its not considered a high risk device per the IVDD.
If their documentation is not up to snuff to support CE Marking then do these things yourself.

The manufacturer places the CE Mark, that would be them not you. If you rebrand it sell it as yours you are also responsible from a legal perspective so verify their technical file or documentation supports placement of the CE Mark per the IVD Directive Essential Requirements (EMC testing has been done to IEC 61326, safety testing completed to IEC 61010-1, risk analysis per 14971, etc). It can be self-certified if its not considered a high risk device per the IVDD.
If their documentation is not up to snuff to support CE Marking then do these things yourself.



Just be a little careful here. From a regulatory perspective, the manufacturer is whoever puts their name on the box. If the product is offered under two different company names, then there are two legal manufacturers. If the product is offered under two different product brand names, but there is a single identified manufacturer, then there is only company that needs to apply the requirements of the MDD/IVDD.


This is also why you need to be very careful with descriptors like:

"manufactured for"
"manufactured by"
etc

The way the UK MHRA has always (semi-officially) interpreted this is basically "whoever's name is biggest on the box, if not otherwise completely unambiguous".

"Distributed by" is usually okay, but then the legal manufacturer must also be clearly identified of course, I would recommend with the legal manufacturer symbol (from EN980) clearly associated with the name.