CE marking - Medical Device - Must have our name and address on it?

[Carl Keller]

I am being told that one of our devices must have our name and address printed on it, or somewhere on the final packaging before we have approval to carry the CE mark.

Basically an oral doser with measurements on it.

Here is the problem, the item is too small to print the info on it and we sell it to a company that packages it with the OTC medicine. They do not know what the final packaging will be because they have not run their trials yet.

Are we missing something or is Europe on a path of obvious failure of the system because nobody is going to bother jumping through hoops to sell there?

Carl-

[Al Rosen]

Originally Posted by Carl Keller

I am being told that one of our devices must have our name and address printed on it, or somewhere on the final packaging before we have approval to carry the CE mark.

Basically an oral doser with measurements on it.

Here is the problem, the item is too small to print the info on it and we sell it to a company that packages it with the OTC medicine. They do not know what the final packaging will be because they have not run their trials yet.

Are we missing something or is Europe on a path of obvious failure of the system because nobody is going to bother jumping through hoops to sell there?

Carl-

You can't get approval without the final packaging. It is not like the US FDA whereby you can submit a 510K with the preliminary label. The CE Mark is only allowed to be applied after everything is completed including all testing and labeling. I and you submit your Technical File for review. Sell it to the company with your labeling and your CE Mark. They can then repackage it with their medicine.

As far as jumping through hoops, I believe they want to keep the business within the EU. They are a large market. Wait till you have to work with China or Japan.

[celeo]

The CE mark ( with the Notified Body number) shall be applied to even low risk devices such as this measuring spoon. Every medical device must conform to Annex I of the Directive, that is the MDD Essential Requirments. That is the baseline for any device legally placed on the market. The technical documentation that goes with the "Manufacturer' Declaration of Conformity to the Essential Requirments and Annex VII and V with your product is covered in the Notofied Body Recommendation NB-MED/2.5.1/Rec5.

In there (page 12/21) you will see the various options as to where the minimum information can be applied. This includes the "Mnaufactuer" name and address and/or the name and address of the European Representative, who must be based in the EU.

However if this is part of another product packaging then that "Manufacturer" (see definition in MDD - it is not the same as the FDA, is the one who supplies this information on their label and or labelling ( to use FDA terminology).

There are ways around many of these things without breaking any law, but it does requires experience and familiarity with the MDD. To help a little bit. The "Manufacturer" is the person who puts the device on the EU market under their own name. In this case your are a supplier, not a "manufacturer'. It is the "Manufacturer " who needs to comply with the regulations.

To jump through this 'hoop' you gain access to the biggest regulated market in the world.

[wrodnigg]

At first, an oral doser with measurements is a class Im product acc. MDD 93/42/EEC

When your product is an accessory to an other product your customer will claim your declaration of conformity and the corresponding CE-certificate from a notified body.

So you need a certificate from a notified body either for your product or for your company (quality management system).

You can follow the procedures of Annex IV, ot V or VI.

You need to print your name and address on:

Annex I, Clause 13.3. MDD
The label must bear the following particulars:
(a) the name or trade name and address of the manufacturer. For
devices imported into the Community, in view of their distribution
in the Community, the label, or the outer packaging, or instructions
for use, shall contain in addition the name and address of either the
person responsible referred to in Article 14 (2) or of the authorized
representative of the manufacturer established within the Community
or of the importer established within the Community, as
appropriate;

In your case you need to print (affix) at least the CE with the number of the notified body on the product itself (eg. printed on the buttom of a cup ot the handle of a spoon).

[Carl Keller]

Thanks for the info, looks like I have some research to do.

This is a stock item that will be sold domestically (U.S.) as well as in Europe. As I said, this device is very small and printing our info is not and option.

We have other (similar) CE marked devices and have never had this problem.

I understand the need for some regulation, but it seems like a lot of trouble/work just to sell over there regardless of the market size. I would think a lot of companies would just say the heck with it, just sell domestically and exclude Europe from the innovation.

In any case, thanks again for the info. I appreciate it.

Carl-