Dear Mailbase
Just a few thoughts from the MHRA perspective:
1.As detailed the blood gas analyser is an IVD an as such will likely only be CE marked for the analysis of whole blood samples.
2.A free standing pH electrode/meter is likely not to have a medical intended purpose and will be a 'product for general laboratory use'. Such products are not covered by the IVD directive, do not have to be CE marked, unless, in view of their characteristics, are specifically intended by their manufacturer to be used for InVitro diagnostic examination.
3. MHRA would not be able to support labs modifying CE marked methods in house and I draw your attention to a Medical Device Alert issued in 2004 regarding off label use and user modifications of CE marked products. This Alert can be viewed on the MHRA website by typing MDA/2004/006
Into the search bar.
You may be interested to hear that I recently spoke at a lunch time meeting of a biochemistry department in a London hospital and one of the comments was that it was nice to know the background to the IVD directive and to understand that it wasn't just introduced by desk bound civil servants to prevent innovation in labs! I'd be happy to visit other hospitals and demystify the IVD directive and the role of the MHRA!
Kind Regards
Andrea Molyneaux
Senior Medical Device Specialist - IVD
Tel: 020 7084 3119
Market Towers, 1 Nine Elms Lane, Vauxhall, London SW8 5NQ
-----Original Message-----
From: David Brown [mailto:[log in to unmask]]
Sent: 13 December 2005 11:58
To: [log in to unmask]
Subject: Re: Pleural fluid pH
"Frost, Stephen" <[log in to unmask]> wrote:
When I was 'brought up' evaluating and validating methods was one of the roles of lab scientists. Is CE marking of itself a limitation on modifying methods in-house?
I agree, Richard. These types of projects are useful for training, real evidence on which to base arguments etc., etc.,-- I think CE marking scares lab scientists into worrying about consequences. If a project is carried out scientifically and with all the protocols and data recorded it will exceed the requirements of CE marking.
David Brown
David G Brown
Valencia
Espaņa
Tel 00 34 96 328 7207
mov. 00 34 676064278
e-mail [log in to unmask]
http://www.proz.com/pro/56276
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