Pale Pilgrim
Registered
Hi,
I have a question in relation to the retention of the Technical Documentation for the required period if a company goes out of business before that period is up.
Per Annex IX Chapter III of the Medical device Regulation:
"Each Member State shall require that the documentation referred to in Section 7 is kept at the disposal of competent authorities for the period indicated in that Section in case a manufacturer, or its authorised representative, established within its territory goes bankrupt or ceases its business activity prior to the end of that period."
How have you addressed this within your QMS?
I have a question in relation to the retention of the Technical Documentation for the required period if a company goes out of business before that period is up.
Per Annex IX Chapter III of the Medical device Regulation:
"Each Member State shall require that the documentation referred to in Section 7 is kept at the disposal of competent authorities for the period indicated in that Section in case a manufacturer, or its authorised representative, established within its territory goes bankrupt or ceases its business activity prior to the end of that period."
How have you addressed this within your QMS?
