User Manual Release before CE Mark

JoCam

Trusted Information Resource
Hi All,

Can the User Manual and Brochure for a class IIa medical device be distributed to potential customers before the medical device itself has received CE Mark?

Jo
 

Pads38

Moderator
I think that situation may be covered by Article 4, Clause 3.
These devices shall not bear the CE marking.

3. 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 - it's OK but you will need an explicit statement that the device is not yet CE marked.
 

JoCam

Trusted Information Resource
Thank you Pads 38,

I know it cannot be displayed on the product itself, and it is common sense that the associated literature should follow suit, but does it actually state anywhere the same rule for the literature? It is all very obvious to me, as you should in no way mislead potential customers as to the status of the device, but as ever, I need evidence.

Thank you again,

Jo
 

Mark Meer

Trusted Information Resource
I know it cannot be displayed on the product itself, and it is common sense that the associated literature should follow suit, but does it actually state anywhere the same rule for the literature? It is all very obvious to me, as you should in no way mislead potential customers as to the status of the device, but as ever, I need evidence.

Wait... you're asking about just distributing the literature?

I don't see how this could possibly be an issue because, of course, the literature is not a medical device. As Pad38 says, just be upfront about the status of the device (i.e. the device presented in this literature is not yet available for sale in the EU).

We send out literature on up-coming devices to interested distributors all the time. I don't think it's anything you have to worry about...

MM
 

shimonv

Trusted Information Resource
I believe sending literature on up-coming device is different than user manual for a device not yet approved. It could be misleading if the final manual might be different that the preliminary version. To be on the safe side I would send the manual with a 'Draft' watermark and no symbols of CE mark + NB number.

Shimon
 

Avraham Harris

Involved In Discussions
Hi all,
I tend to agree with Pad38 and ShimonV that a CE marked user manual is misleading and may not be distributed prior to CE mark.

Mark, while true that the User manual is not a device, it refers to a device, and if it seems to indicate that that device is CE-marked prior to actual conformity assessment (or DoC), then this is illegal. Moreover, one could not claim that the manual is not a device, because then the CE mark could not be placed on it (EU regulations do not allow CE to be placed on something that is not *subject* to CE mark - see bottom of https://ec.europa.eu/growth/single-market/ce-marking_en)
 
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