CE Mark Medical Devices - Annexes II, IV, V and VI

[M & M]

We manufacture TENS units and attach electrodes and lead wires to the device. Can we place the CE mark followed by the registrar's number on the electrodes and lead wires? Our auditor has given us a nonconformity for using the registrar's number. We don't want to remove the number. Thanks for any help.

M & M

[Al Rosen]

Originally Posted by M & M

We manufacture TENS units and attach electrodes and lead wires to the device. Can we place the CE mark followed by the registrar's number on the electrodes and lead wires? Our auditor has given us a nonconformity for using the registrar's number. We don't want to remove the number. Thanks for any help.

M & M

What Annex are you following? Article 17 of the MDD requires the identification number of the notified body to accompany the CE mark for annexes II, IV, V and VI only. In addition article 17, 3 states: It is prohibited to affix marks or inscriptions which are likely to mislead third parties with regard to the meanings or the graphics of the CE marking. So if you are following an annex other than the above ones, you may not use the notified body's id no with the CE mark.

[M & M]

Thanks Al for your prompt response. I appreciate it. We are using Annex IX so it looks like we will have to remove the number.

[terrywan]

ANNEX IX？？
Annex IX is only classification criteria.
If your product is class I, you can use annex VII "EC declaration of conformity". In this situation, you not need NB verification and you can not use NB number

[Al Rosen]

M & M, Terry is correct. Are you confusing classification (Article9) with the conformity assessment procedures(Article 11)? What is the classification of your device according to Annex IX? What rule did you use to determine the class? Are the leads considered separate devices? If so, they are considered separately from the TENS unit for classification.