Technical Documentation - Manufacturing Specifications

[acro14]

Hello,

the directive 93/42/EEC and the future MDR requires the manufacturing specifications to be part of the technical documentation of a product. For a physical manufacturer this requirement is easy to fulfil but If I ask a supplier being the legal manufacturer of the product to hand over the manufacturing specifications he might hesitate to do this because he does not want me to take a closer look at the manufacturing process or he does not want to share sophisticated manufacturing techniques.
So what are the minimum requirements of such a document taking into account the restrained policy of the supplier?
I really appreciate your responses on this topic.

acro14

 

[Ronen E]

Hello,

the directive 93/42/EEC and the future MDR requires the manufacturing specifications to be part of the technical documentation of a product. For a physical manufacturer this requirement is easy to fulfil but If I ask a supplier being the legal manufacturer of the product to hand over the manufacturing specifications he might hesitate to do this because he does not want me to take a closer look at the manufacturing process or he does not want to share sophisticated manufacturing techniques.
So what are the minimum requirements of such a document taking into account the restrained policy of the supplier?
I really appreciate your responses on this topic.

acro14

Are we talking about a component supplier or about a contract manufacturer / OEM for the entire device (or a very big portion of it)?

 

[yodon]

Let me toss out an example (acro14 - see if this is representative).

Company wants to make a device to measure some electrical signal in the body. Supplier has electrodes that will fit the bill. Suppliers manufacturing processes, though, are IP so they won't share with device company and so device company can't include them in the technical documentation.

In the US, you can tell the FDA this is IP and they have the right to go to the supplier and review that documentation. This protects the supplier from exposing IP.

 

[acro14]

Hello Ronen E,

no we are talking about a contract manufacturer. In the case of a component supplier the problem I described would barely emerge.

 

[Remus]

The easiest way is performing some verification activities to purchased products.

For instance you are producing sutures and needle. You are buying sutures and needles then you perform assembly and sterilization. But neither of the supplier will provide you their validations or manufacturing documents because of confidentiality. To solve this problem you can verify each lot. For sutures EP tests and a simple chemical characterization (FTIR spectrum) will most probably enough to convince Notified Bodies and component authorities. Also make suppliers get CE Certificate (if avaible) and ISO 13485 Certificate it also a plus.