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?
