Dear Experts
Need advise again.
Currently we have CE marking for a Medical Device procured from a OEM under OBL route with a product model name 'XXX'. This is obtained under Full Quality Assurance - Annexure II. (Here the complete TF of the OEM is submitted from Design to manufacture - we only issue Labels and IFU with our Model name XXX)
Now we want to do 'manufacturing' of the same product with an agreement with the OEM that they supply us all the components. The final product will be exactly same as product 'XXX' in every aspect. We do not want to change the Model name of the product.
The questions are:
1. Do we have to build the TF again and get fresh CE marking approval by NB or
2. Do we have to mention only as significant change of 'manufacture' moved from OEM to our factory
3. Under which Annexure do we have to apply - Annex II Full Quality or Annex V - Production Quality?
Need advise again.
Currently we have CE marking for a Medical Device procured from a OEM under OBL route with a product model name 'XXX'. This is obtained under Full Quality Assurance - Annexure II. (Here the complete TF of the OEM is submitted from Design to manufacture - we only issue Labels and IFU with our Model name XXX)
Now we want to do 'manufacturing' of the same product with an agreement with the OEM that they supply us all the components. The final product will be exactly same as product 'XXX' in every aspect. We do not want to change the Model name of the product.
The questions are:
1. Do we have to build the TF again and get fresh CE marking approval by NB or
2. Do we have to mention only as significant change of 'manufacture' moved from OEM to our factory
3. Under which Annexure do we have to apply - Annex II Full Quality or Annex V - Production Quality?