Medical devices are CE mark but not sold in EU - Need to comply with REACH?

Dear All ,

My company is going to develop a medical device that will be sold outside EU. Do I need to comply with EU REACH regulations?

My understand is EU REACH is only applicable to medical devices sold into EU market.

Looking forward to your reply.

Where is the product manufacturered? Is it ever imported into the EU?

I am not an expert on REACH, but I think it applies to the manufacture and production stages (not just placing on the market)

Hi, pkost,

The product is manufactured in India and it will not be imported to EU. The CE marking is only for marketing purpose.

Hi,
Of course, if you want to CE mark your medical device, you have to fulfill the whole regulations which applies for the device!
It is not only a label. With this CE mark, you say that this medical device fulfills all the regulations of the council directive 93/42/EEC, Annex I, essential principles.

A product can only have one CE mark. The CE mark means that the product is compliant with ALL applicable directives. So it is not possible to select some Directives and ignore others. In your case it should also be compliant with RoHS (and possibly others).

Ron Boumans said:

A product can only have one CE mark. The CE mark means that the product is compliant with ALL applicable directives. So it is not possible to select some Directives and ignore others. In your case it should also be compliant with RoHS (and possibly others).

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Why do you think that you have to comply with all directives? It has been indicated that the product is not sold in the EU and is not imported into the EU. The directives are therefore not a requirement and cannot be enforced

The potential risk is if the local markets where the product is being sold consider the presence of a CE mark to be deceptive marketing

Hi Pkost,
The CE mark means nothing more or less than a statement by the manufacturer that the product complies with all applicable European legislation. If a product is not compliant with an applicable Directive and the manufacturer still applies the CE mark he is in breach of European rules. It would not be allowed to place such a product on the European market.

Markets outside Europe may accept the CE mark. This is done under the presumption that a product with a CE mark can be freely distributed on the Community Market. A CE marked product that is not compliant with all applicable directives can not freely move in the community. This use of the CE mark could therefor be considered a form of fraud by local authorities.

And there is more to this. If a non-compliant product is yet CE marked for distribution outside Europe, it may still end up there. It is possible that such a case leads to criminal investigations to companies and individuals.

I agree with all your points, however unless the manufacturer intends to place the product on the EU market, there is little to no legal recourse from the EU; even if it makes its way into the EU via other channels, the appropriate response is "we did not place it on the EU market".

Fundamentally it is not a breach of the directives to sell a product carrying a CE mark outside of the EU when it does not comply with the appropriate directives. It is a seperate discussion as to whether you should or not.

In some countries where EC marketability is accepted as an indication of medical device safety and effectiveness, the CE Mark must be documented. Applying a CE Mark on your own, illegitimately, would be regarded as intent to circumvent the local laws on medical device quality.

That for instance would be the case in Australia or Taiwan.

Maybe the OP markets this product in a more gullible country?

even if it makes its way into the EU via other channels, the appropriate response is "we did not place it on the EU market".

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I'll bet this argument would not be accepted by the judge.

The actions of a distributor are not the distributor's ultimate responsibility. A Manufacturer is responsible for the actions of their distribution chain. The Manufacturer of a device is responsible for its marketing, period.

If the Manufacturer applies the CE Mark illegitimately, apparently with intent to fool end users in some less regulated country, and the product ends up in the EC, the Manufacturer will be on the hook.