First of all I would like to thank you all for contributing with your expertise in this marvelous forum.:applause:

I was given a big assigned by my boss: getting our first device CE certified. I move very comfortably on requirements regarding pharmaceutical products because I’ve been working with medicines for almost 10 years but the medical devices are an all new world to me.:frust:

My assigned mission is: register a single use sterile solution as a class IIa device. Our subcontracted manufacturer has the CE mark certification on his brand product. The only difference between their product and ours is the brand (packaging and label with our brand)
The subcontractor doesn´t have the iso certification, only GMP certification (for Pharmaceutical industry) and we don´t have QMS certified.

My questions are:
- Which Annex of the MDD you advice for my case?
- How do I structure the technical file for class II devices?
- Is clinical data mandatory for this device?
- Can I use the CE mark of the subcontract manufacturer to get my CE mark?

Do you have a technical file template or structure guidance that you could make available for me in the forum that involves subcontracting?

Thanks in advance for every help you can give me. :D

Jalocas

First of all I would like to thank you all for contributing with your expertise in this marvelous forum.:applause:

I was given a big assigned by my boss: getting our first device CE certified. I move very comfortably on requirements regarding pharmaceutical products because I’ve been working with medicines for almost 10 years but the medical devices are an all new world to me.:frust:

My assigned mission is: register a single use sterile solution as a class IIa device. Our subcontracted manufacturer has the CE mark certification on his brand product. The only difference between their product and ours is the brand (packaging and label with our brand)
The subcontractor doesn´t have the iso certification, only GMP certification (for Pharmaceutical industry) and we don´t have QMS certified.

My questions are:
- Which Annex of the MDD you advice for my case?
- How do I structure the technical file for class II devices?
- Is clinical data mandatory for this device?
- Can I use the CE mark of the subcontract manufacturer to get my CE mark?

Do you have a technical file template or structure guidance that you could make available for me in the forum that involves subcontracting?

Thanks in advance for every help you can give me. :D

Jalocas

Annex II
There are threads here in the Cove that discuss the Tech File including this one (http://elsmar.com/Forums/showthread.php?t=19806&highlight=technical+file). If you need more information, you can do a search in the cove.

Clinical Data is necessary, but it can take the form of a literature review.

I believe if you put your name on the device, you need the CE Mark and cannot rely on your subcontract mfr.

Dear Jalocas,

I do not fully agree with the above reply.

What you would like to do is to become Private Label Manufacturer. This is quite common among manufacturers of medical devices.
What it means is that some CE certified manufacturer (an OEM manufacturer) is manufacturing his products with different brand.

If this is what you want to do than all is quite easy.

the choice of the annex depends on your plans and further development and the certificate your OEM manufacturer has.
the structure of TF should generally follow NB-MED/2.5.1/Rec5.
IMHO the clinical data may not be obligatory - to some extent it depends on the annex you choose.
you can of course use the EC approval they have. basing on what you just said you must base on their certificate :)

Generally speaking you take their certificate, present it at your notified body and say: Look! we have their product and want to have it under our brand. If you do no changes in this respect (just the label) their EC approval will do to say the product is safe to the patient.

Of course there are some tricky points and hard issues but it's much easier to certifying all the production processes.

If you gave me some more details about your products, plans and location I could give you detailed guidelines.
I could advise for the choice of auditors as well - I know some who are very familiar with this concept and will be more than happy to assist with the audit.
Should you need to those pieces of information please pop my an @ at prolexum@yahoo.pl or via the Cove.

Thank you Gereard and Al for feedback me in less that 24h.

Gereard I will pop you at prolexum@yahoo.pl.

;)