CE Marking for Class I Medical Devices - Self-declare CE marking?

[melisa7421]

Hello,

Kinldy help me on this question? Have a potential client would like to self-declare CE marking for Class I medical device product.

For CE MArking
1. What Product testing need to be done for an automatic dialyzer reprocessing system?
2. Where can I obtain those information?
3. What are the lab recognised in Singapore or Malaysia by EU?

Thank you.


Melisa

[celeo]

The combination of words dialyser, reprocess with 'self declaration Class I' for CE marking do not match. I would strongly recommend a review of the stated intended use of the device - it appears to be reprocessing of dialysers? This in itself may be contrary to the orginal manufacturers intended use. After that, there needs to be a close examination of sterility issues before re-use, even on the same patient. As soon as sterilization comes into the picture the device can not be under Class I self declaration for CE marking. My recommendation would be to seek the advice of a Notified Body competent in this segment of the medical device market. - Leo

[SilverHawk]

Perhaps, Melisa 7421 should discuss with her client whether they have study together the classification rule of their "product" intended for use!

Or it is that these "products" are "collected" back from the haemodialsysis center and "recycle/reprocess" and return to healthcare centers!!!!!!

[wrodnigg]

According to the MDD Rule 3, HD filters are class IIb: Devices that modify biological or chemical composition of blood, body liquids or other liquids.

For questions on reuse of haemodializers I would strongly recommend to read:
ANSI/AAMI RD47 "Reuse of hemodialyzers".

~ghw

[BRIAN777]

You should have MMD 93/42/EEC and MEDDEV 2.4/1 Rev. 8 for Guidlines for the classification of Medical Devices on hand to take the proper path to CE declaration.