Instructions for Use - Ob/Gyn products sold in Europe - CE mark and the NB number

[Rajesh Anantharaman]

Hello Covers,

Thanks for being such a great help in answering all the questions and posting interesting discussions regarding Quality and other topics.

One question regarding Instructions for Use. We make Ob/Gyn products which we sell to Europe. We are CE Certified and want to know if the CE mark and the NB number should be included in the IFUs? I tried looking at the MDD but couldnt get the requirement.

Please advice.

Thanks and Wish you all a Merry Christmas and a Happy New Year.

Rajesh

[Roland Cooke]

Article 17 of the MDD is what you need (emphasis mine).

Article 17
CE marking
1. Devices, other than devices which are custom-made or intended for clinical investigations, considered to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market.
2. The CE marking of conformity, as shown in Annex XII, must appear in a visible, legible and indelible form on the device or its sterile pack, where practicable and appropriate, and on the instructions for use. Where applicable, the CE marking must also appear on the sales packaging.
It shall be accompanied by the identification number of the notified body responsible for implementation of the procedures set out in Annexes II, IV, V and VI.
3. It is prohibited to affix marks or inscriptions which are likely to mislead third parties with regard to the meaning or the graphics of the CE marking. Any other mark may be affixed to the device, to the packaging or to the instruction leaflet accompanying the device provided that the visibility and legibility of the CE marking is not thereby reduced.

The CE mark (and NB number if applicable) should therefore appear both on the IFUs and also on the packaging labelling.


Strictly speaking the CE mark should not appear on marketing (etc)documentation, since a magazine advert itself cannot actually be CE-marked. (That said, as long as the use of the mark is not "offensive" to the authorities, it is unlikely that enforcement action would be taken. Nonetheless, best to be avoided!)

[Rajesh Anantharaman]

Hi Roland,

Thank you for your help.

Rajesh

[Mike S.]

"Instructions for Use - Ob/Gyn products sold in Europe"

I had only read this far into the post description (see above) and figured, I just GOTTA see this one!