Hi, as the title asks, if I buy an off the shelf product to use as part of my medical device, which I will then sell as a spare part also, do I become the legal manufacturer for that part? Does it matter if that part is CE marked by the OEM? Does the situation change if the device is classified as an acessory rather than a spare part?
The MHRA guidance on this states that "A virtual manufacturer is an organisation that fully sources its own named product from another company (sometimes known as the ‘original equipment manufacturer’), which has designed and manufactured an identical CE marked product", so I'm unsure if the legal manufacturer obligations apply only to a final device rather than a spare part or component? Thanks
The MHRA guidance on this states that "A virtual manufacturer is an organisation that fully sources its own named product from another company (sometimes known as the ‘original equipment manufacturer’), which has designed and manufactured an identical CE marked product", so I'm unsure if the legal manufacturer obligations apply only to a final device rather than a spare part or component? Thanks