Requirement for independent certification of device using an ISO 17025 laboratory

rob73

looking for answers
#1
Hi Guys
What do we think about the requirement for device to have independent certification using an ISO 17025 laboratory. A friend has been asked for this in a new NHS contract, setting aside that if this is a new contractual agreement he may not have any choice, is this strictly necessary for CE marking a class 11a device? BTW he's being asked for certification to [FONT=&quot]BS EN ISO 8836:2014 suction catheter by an ISO 17025 test house.
****edit*****
Since found out that BS EN ISO 8836:2014 does not appear in the official journal, so it is not harmonised, but could still be considered stat of the art??



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Last edited:
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Ronen E

Problem Solver
Staff member
Moderator
#2
I don’t know about the NHS, they may require whatever they like (and seem to be doing so).
Regarding CE marking, I assume the reference is the MDD, not MDR - correct?
If so, it’s not an MDD requirement for CE marking a class IIa catheter, unless the manufacturer chooses to go the annex III/IV route. Did they?
 

rob73

looking for answers
#3
HI Ronen
As always thanks for the input, i have suggested that he the contacts the manufacturer of the catheter (he is the EC rep and distributor) and find out how the product has been CE marked and if any standards were used to gain it. As for the NHS, i suspect that someone has just given the buyer a checklist of requirements without actually understanding what they are asking for.
 
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