B
I've just been talking to a registrar about the transition options available to us and wanted to check out if his approach is different to other people's experience.
We have CE marking via Annex 7 supported by 9002:94 and 46002:96.
He suggested that 9002:94 is not necessary to support CE marking so long as we maintain the 46002 QA system and meet the specific requirements of the Medical Devices Directive. So we could allow the 9002 to lapse.
In parallel with this we should develop systems that comply with 13485:2003 which he says should be complete by July this year. We could then register to this at our next annual visit in the Summer of next year.
This seems like quite a light approach and takes the pressure off our transition programme this year, and gives us until next Summer to move across to the new approach.
Is this a common interpretation ? I'd welcome any feedback about the transition route other people are taking.
Bill Marshall
We have CE marking via Annex 7 supported by 9002:94 and 46002:96.
He suggested that 9002:94 is not necessary to support CE marking so long as we maintain the 46002 QA system and meet the specific requirements of the Medical Devices Directive. So we could allow the 9002 to lapse.
In parallel with this we should develop systems that comply with 13485:2003 which he says should be complete by July this year. We could then register to this at our next annual visit in the Summer of next year.
This seems like quite a light approach and takes the pressure off our transition programme this year, and gives us until next Summer to move across to the new approach.
Is this a common interpretation ? I'd welcome any feedback about the transition route other people are taking.
Bill Marshall