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CE Mark for Medical Devices Sold in Europe

Bryan Kiehl b3748 at cts.com
Thu Nov 2 22:07:22 EST 1995

schneip at interactive.net (Paul Schneider) wrote:

>Could one of the UK readers of these newsgroups provide me by e-mail
>or posting to these newsgroups a copy of the Guidance Notes For
>Manufacturers seking to comply with the EC Directive for Medical
>Devices CE Mark Status issued by the Medical Device Agency. One of my
>clients has written to the agency at it's Russell Square, London
>address requesting the item and has received no reply to date. I
>realize that it may yet arrive, but knowing the red tape involved and
>the liklihood that it went by surface mail, I decided to try this
>newsgroup route. If you send me the document by e-mail please post
>that fact to these newsgroups so that my mail box doesn't get
>inundated with replys ;-).

>Thanks in advance for any help. BTW does the MCA have a presence on
>the Intenet? What about the EC divisions or committees involved with
>Medical Directives?

>Paul Schneider

>Paul Schneider, Ph.D., RAC    |Paul Schneider,Ph.D.& Associates
>schneip at interactive.net       |     Regulatory Consultants
>74604.2211 at compuserve.com     |    Serving the Needs of the
>548 Stevens Avenue            |      Health Care Industry
>Ridgewood, NJ 07450           |Tel:201-652-0706 FAX:201-652-1289

This is an interesting topic. I work in a company that makes in vitro
diagnostic devices. It is my understanding that we do not need to be
ISO certified to obtain a CE mark, but do need to register. Can anyone
discuss this topic for diagnostic lab tests?

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