D&D (Design and Development) Requirement for Semi-Finished Products

C

Cinti

#1
Hi,

We are procuring semi finished products from a well established supplier. Here, we are doing just sterilization and packing process. We are the manufacturer of this product. Can anybody explain me the design and development requirement of this product for getting CE certificate since we don't have any design control?

Cinti
 
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Stijloor

Staff member
Super Moderator
#2
Hi,

We are procuring semi finished products from a well established supplier. Here, we are doing just sterilization and packing process. We are the manufacturer of this product. Can anybody explain me the design and development requirement of this product for getting CE certificate since we don't have any design control?

Cinti
Can someone help Cinti?

Thank you.

Stijloor.
 

somashekar

Staff member
Super Moderator
#3
Hi,

We are procuring semi finished products from a well established supplier. Here, we are doing just sterilization and packing process. We are the manufacturer of this product. Can anybody explain me the design and development requirement of this product for getting CE certificate since we don't have any design control?

Cinti
Hi Cinti ...
You have a good contract (an agreement) with the well established supplier to provide you with the latest and updated design file, risk management file and manufacturing / testing documentation file upto the pre sterilization process. Add to this your sterilization process and labelling , packaging process documentation and complete the technical file of your product for the NB review and CE certfication. Make sure the well established supplier is also made to agree for taking up your NB audit at his site per the directive and Technical file inputs.
Note: If your responsibility includes clinical evaluation, this adds to the technical file along with your risk management and essential requirements checklist. Your contract with the well established supplier must also capture sharing inputs of these documents as applicable.
Ask your NB if this suffices ~~~
 
Last edited:
C

Cinti

#4
What the problem is, the supplier haven't provided the design document and risk assessment document. We had received Non conformance and we are finding difficulties for closing this NC because of non-cooperation from the supplier.
 

somashekar

Staff member
Super Moderator
#5
What the problem is, the supplier haven't provided the design document and risk assessment document. We had received Non conformance and we are finding difficulties for closing this NC because of non-cooperation from the supplier.
Very common problem as you have not considered regulatory requirements at an early stage of your association with your well established supplier. The better way is to negotiate with the supplier on a new terms of business which will include his sharing of Technical file information etc., and updates as he makes and his costs associated.
Please be aware that there is a major cost component of regulatory compliance to be incorporated into your product costing.
:topic: Nothing comes free Cinti, but for the air we breathe (polluted in city ~~~)
 
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