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Class I Device - Reusable Instruments labeling requirements

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Posted 30th January 2014 at 12:13 PM by sherley13

Reusable Surgical Instruments are Classified as Class I device according to MDD 93/42/EEC, the device “Forceps” selling in EU country what is the labeling requirements for the distributor. The following are my question.

1.Does Class I – Reusable instrument device require CE mark on the label?
2. Distributor has to mention “Original Manufacturer name and address, CE mark, and EU Representative address ” /or Just only we need to be mention “Distributed by: our name and address” is sufficient.?

Pl help.
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  1. Old Comment

    Class IIb medical device

    Hi Covers,

    It's my first time posting on this forum. i have found this forum to be very informative and helpful. I work for an organisation that designs and manufacture medical device class IIb. We currently hold an ISO 13485 certificate (recertifed last year) and our device holds a CE mark. We are in the processing of modifying our medical device, do we need to have the CE certificate for this improved device, do we need to also go for pi mark certificatation? Please advise, your help will be highly appreciated.
    Posted 4th February 2014 at 10:48 AM by mathenga mathenga is offline
  2. Old Comment
    Hello everyone,

    My problem is that I can not find a CE mark ont he packaging of the Polyethylenfolie gloves. I think the PE gloves are medical devices.

    Thank you for your help
    Posted 12th February 2014 at 02:28 PM by Sztpyol Sztpyol is offline
 
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