Medical Device and Importation Requirements for Tradeshows in EU

[MJW66]

We have a legally marketed device in the USA (class II), but would like to exhibit this same device in the EU at an upcoming tradeshow. It does not currently bear CE marking, but we plan to pursue this shortly. This would be a Class I device in the EU. What are the restrictions for doing so? The marketing department just asked me if they can send a shipment over in preparation. I'm sure that it would get held up at importation. Also, are there any preselling restrictions? Thanks in advance.

[Al Rosen]

In Reply to Parent Post by MJW66

We have a legally marketed device in the USA (class II), but would like to exhibit this same device in the EU at an upcoming tradeshow. It does not currently bear CE marking, but we plan to pursue this shortly. This would be a Class I device in the EU. What are the restrictions for doing so? The marketing department just asked me if they can send a shipment over in preparation. I'm sure that it would get held up at importation. Also, are there any preselling restrictions? Thanks in advance.

You can find the answer in the MDD.

[Adele]

Hi - Article 4, 3 of the MDD reads:

"At trade fairs, exhibitions, demonstrations, etc. Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that a visible sign clearly indicates that such devices cannot be marketed or put into service until they have been made to comply."

So as long as you do this at the trade show, you should be fine. I have never had a proplem with importation of the device in EU.

Hope this helps.

Cheers

[MIREGMGR]

Also contact your trade show's customer service people, who will be completely familiar with the regulatory issues applicable to medical device transport across national borders to and from their show.