Requirements for Medical Device exhibition in Dusseldorf of Germany (2012 MEDICA)

[Roland chung]

Hi all,

We are planning to participate in the medical device exhibition in Dusseldorf of Germany (2012 MEDICA).

Since it is the first time for us, as a foreign company, to attend such exhibition, could you please tell me if the demo products need to comply with the CE requirements? If not, what requirements should the demo products comply with?

Thanks and regards,
Roland

[CharlieUK]

Equipment displayed at exhibitions does not need to be CE marked and compliant with relevant directives, provided that the equipment is suitable labelled as such and you should make it clear that the product is not yet CE marked, but will be before it is sold or put into service

You don't say exactly what the equipment is, but it you need to connect it to ac mains supply the exhibition organisers may want to see some proof that it is safe.

[somashekar]

In Reply to Parent Post by Roland chung

Hi all,

We are planning to participate in the medical device exhibition in Dusseldorf of Germany (2012 MEDICA).

Since it is the first time for us, as a foreign company, to attend such exhibition, could you please tell me if the demo products need to comply with the CE requirements? If not, what requirements should the demo products comply with?

Thanks and regards,
Roland

MDD 93/42/EEC
Under Article 4:
Free movement, devices intended for special purposes
at 3. These devices shall not bear the CE marking.
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.

[yodon]

Adding on to what CharlieUK noted, I don't know if it's a requirement, but just about all I've seen (and had to deal with in such capacity) are marked (labeled) "Not for human use."

[MIREGMGR]

In Reply to Parent Post by Roland chung

We are planning to participate in the medical device exhibition in Dusseldorf of Germany (2012 MEDICA).

Since it is the first time for us...

I haven't been to Medica in a few years, but it used to be the case that the in-facility restaurants intended for the exhibitors were quite expensive, overly rich given that everyone had to be at least somewhat sharp for the afternoon, and not much of a "Germany" experience.

There used to be, outdoors in the center of the building-group, a semi-open-air cafeteria-style eating facility intended for the workers, but accessible to anyone who knew it was there. The menu tended toward hearty, tasty working-class fare, the accommodations were practical but quite adequate as long as it wasn't precipitating, the nominal language was German but the order takers could handle enough English that everything worked, and it cost maybe a third as much.

Check it out. If it hasn't changed, I'd highly recommend it for every lunch.

There was also a small store nearby that seemed to sell anything you could think of that a show exhibitor might want to buy. Very useful.

[Roland chung]

Thank you all.

So, there are no requirements for the demo device provided that the device is labelled as "Demo Product, Not For Human Use". Does any further marking should be considered?

In Reply to Parent Post by CharlieUK

You don't say exactly what the equipment is, but it you need to connect it to ac mains supply the exhibition organisers may want to see some proof that it is safe.

It is dental unit. What proof should we show to the organizer?

[Pads38]

You don't really need "Not for human.." just a sign that says "This product is not yet CE marked so is not yet available for sale in the EU"

And you are not allowed to take "pre-orders" or other psuedo-sales.

[Roland chung]

And you are not allowed to take "pre-orders" or other psuedo-sales.

Where can I find this provision? thanks

How about the product that has been CE approved?