C
claireyvb
Hi Covers,
What are people's takes on the conduct of risk assessments for own brand labeller manufacturer's products (Class I and IIa)?
To expand: We are an OBL in UK who buy Generic Medical Devices that are already CE Marked and available on the market and literally have the product put into our Product livery by the OEM. We then register it with ourselves being the legal manufacturer with an NB/MHRA as applicable.
We receive the OEM's risk assessment as part of the Technical File and we have outgoing and incoming QC inspections on each lot shipped to/received by us. Neither the product's function nor its internal design are amended in any way. Should we, as unskilled individuals, be conducting a secondary risk assessment on the products?
Thanks for your input in advance.
Claire
What are people's takes on the conduct of risk assessments for own brand labeller manufacturer's products (Class I and IIa)?
To expand: We are an OBL in UK who buy Generic Medical Devices that are already CE Marked and available on the market and literally have the product put into our Product livery by the OEM. We then register it with ourselves being the legal manufacturer with an NB/MHRA as applicable.
We receive the OEM's risk assessment as part of the Technical File and we have outgoing and incoming QC inspections on each lot shipped to/received by us. Neither the product's function nor its internal design are amended in any way. Should we, as unskilled individuals, be conducting a secondary risk assessment on the products?
Thanks for your input in advance.
Claire