Re: CE Marking a CE marked Class I Medical Device - To aid approval/registration in C
To aid approval/registration in China of our Class III device, it has been suggested that the easiest way to do this is to first obtain a CE mark for a Class I device.
As a consequence I am considering asking an instrument company that I know to provide one of their CE marked instruments (and access to their technical file), mark with our company name and submit this Class I device for EC Design Examination.
Would anyone on the Cove be able to advise what documentation is required...on the basis I can refer the the original manufacturers CE mark approval.
Thoughts/advice appreciated
Thank you.
Hello,
Class III with Class I certification procedures are similar by a small percentage.
For Class III certification you need a notified body (Europe-based at
http://ec.europa.eu/enterprise/newa...99999&prc_id=99999&ann_id=99999&prc_anx=99999 - you may ask them for their Chinese counterpart if existent, or search for a local list of NBs).
For Class I you self-certify the compliance with the essential requirements of the Medical Device Directive 93/42. This means you do not involve a NB at all (except if your device has measuring function or if it is sterile).
Check the classification rules (
http://www.meddev.info/ - although there have been some amendments to these lists and they are not totally up to date) and see whether you can only classify your product as Class I.
Make note that you need to have the correct labeling on the product/packaging, therefore if you have a Class III special wound dressing but want to market it as Class I, then you need to clearly indicate on your packaging and/or instructions that your special wound care product should only be issued as a mechanical barrier (... as a tissue!).
Keep in mind that in the latter case you are risking to be accused of fraud and/or unfair competition (because a competitive Class III product may look alike, and has incurred the cost of certification, which you avoided). I have seen this happening! Also, one could say that marketing a Class III product as Class I (to avoid the NB) jeopardizes patients' safety, and if something goes wrong with a patient you never know how you will be affected if you get what I mean.
Therefore may be it is a good idea to consult a NB who will tell you the whole proper procedure, and do it right from the beginning.
Good morning!