Implementing Risk Management for Contract Manufacturers - ISO 13485

M

Metal63

#11
Re: Implementing Risk Management for Contract Manufacturer - ISO 13485

Thanks Miregmgr. I will look into adding that into the risk plan.
 
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M

MIREGMGR

#12
Re: Implementing Risk Management for Contract Manufacturer - ISO 13485

Our scope is Contract Manufacturer of non-sterile components and assemblies for commercial and medical industry.
The definition of "Contract Manufacturing" for European regulations is less than perfectly clear, because there are differences between German and British guidances in that regard. For US FDA, though, "Contract Manufacturing" means by definition that you build completed devices, which you have to List, and for which you have some degree of secondary regulatory responsibility in conjunction with the Specification Provider.

If in fact your intent is only to build components and assemblies, it sounds to me as if you instead will be a 21CFR 807.65(a) "Component Maker".
 

Ronen E

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Moderator
#13
Re: Implementing Risk Management for Contract Manufacturer - ISO 13485

The definition of "Contract Manufacturing" for European regulations is less than perfectly clear, because there are differences between German and British guidances in that regard. For US FDA, though, "Contract Manufacturing" means by definition that you build completed devices, which you have to List, and for which you have some degree of secondary regulatory responsibility in conjunction with the Specification Provider.

If in fact your intent is only to build components and assemblies, it sounds to me as if you instead will be a 21CFR 807.65(a) "Component Maker".
As far as I'm aware, EC regulation doesn't directly address "Contract Manufacturing", and any expectations from such entities are applied via the legal manufacturer (or NB formally auditing the legal manufacturer).

The following guidances may be of relevance to subcontractors (be they contract manufacturers of finished devices or component makers) supplying to legal manufacturers that place their finished medical devices on the EC market:

http://www.meddev.info/_documents/R2_15-1_rev3.pdf
http://www.meddev.info/_documents/R2_5_2-1_rev4.pdf
 
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