Morning
We are about to sell a prototype inspection lamp using new technology lighting source, developed here in Wales. The end user is English and it will not be re-sold, probably returned to us for further improvements. I appreciate when we go into production, it will be necessary, but do we have to CE mark it as a prototype?
Paul

I don't think so. you don't have to CE mark a prototype. Only products that go to the market.
AV:)

Antonio
Thank you for your reply. No-one seems to know the answer to this one!
Paul

sonflowerinwales,

European Union has lots of available and free technical information.
You can go to http://www.newapproach.org/ where you can find and download completely free everything you want to know about CE Mark.

[...with a little lag...]

You do not need to CE-mark a prototype, as long as it is a "device intended for clinical investigation" (MDD Article 2 (e)), which means any device
intended for use by a duly qualified medical practitioner when
conducting investigations as referred to in Section 2.1 of Annex X
in an adequate human clinical environment.

1. In the case of devices intended for clinical investigations, the
manufacturer, or his authorized representative established in the
Community, shall follow the procedure referred to in Annex VIII and
notify the competent authorities of the Member States in which the
investigations are to be conducted.

For more information on this topic please refer to Article 15 and Annex X of the MDD.