Regulatory Open Forum

Is a contract manufacture who is providing a device design to customer requirements ever expected to ensure the client is meeting all of their regulatory requirements, say with registrations or submissions?  I'm thinking in terms of Clause 5.2 of ISO 13485, if I know a client's regulatory strategy is not meeting applicable regulatory requirements is it the contract manufacturer's responsibility to ensure they are aware of those requirements or that they are also fulfilling them?

Hello, 

In regards of clause 5.2 of ISO 13485, it interpretes top management is responsible to meet customer's requirement and provide satisfactory services to their customer, this can be done by internal assessment, customer feedback and provide details of your products and services to customer. It refers to your customer's need, so if you have made an agreement with client for device design services only with clarification of compliance responsibilities it is out of the scope that you are responsible for submission or regulatory deficiency.

A part of clause 5.2 states responsibility of top management to any applicable regulatory requirements are met. which refers to compliance of your organisation to applicable regulatory requirements to offer service or product to your customer.

You can direct them to re-strategize their pathway or work to fulfill regulatory requirement as a professional advise, but it is not your responsibility to ensure that the regulatory strategy is meeting requirements. (Unless stated otherwise in agreement.) 

I hope this helps.

Regards,

Rutvik Patel, MSRA

Is a contract manufacture who is providing a device design to customer requirements ever expected to ensure the client is meeting all of their regulatory requirements, say with registrations or submissions?  I'm thinking in terms of Clause 5.2 of ISO 13485, if I know a client's regulatory strategy is not meeting applicable regulatory requirements is it the contract manufacturer's responsibility to ensure they are aware of those requirements or that they are also fulfilling them?

Good day Anon,

In a simple answer: no, because the Contract Manufacturer would not have any regulatory responsibilities.  With that said, the (legal) Manufacturer of the device should be conducting all of the proper regulatory compliance activities such as available technical documentation, registration, maintaining registration, post market activities, etc.  In context of ISO 13485, each quality system owner is responsible for their own quality system and scope defined by the quality system.  If there are customer requirements the Manufacturer places on the Contract Manufacturer which top management needs to be aware, then this should be defined by a Quality Agreement and potentially in the Contract Manufacturer quality system, e.g. Quality Manual.  In a customer/supplier relationship it would be quite rare to have the Contract Manufacturer exert requirements on their customer, the Manufacturer, though it could happen.  This would then again be clearly defined in a quality agreement or contract between the two companies.  Ultimately, the (legal) Manufacturer has the end-product regulatory responsibility, but this could be sole responsibility or shared between the companies.

Hello, 

In regards of clause 5.2 of ISO 13485, it interpretes top management is responsible to meet customer's requirement and provide satisfactory services to their customer, this can be done by internal assessment, customer feedback and provide details of your products and services to customer. It refers to your customer's need, so if you have made an agreement with client for device design services only with clarification of compliance responsibilities it is out of the scope that you are responsible for submission or regulatory deficiency.

A part of clause 5.2 states responsibility of top management to any applicable regulatory requirements are met. which refers to compliance of your organisation to applicable regulatory requirements to offer service or product to your customer.

You can direct them to re-strategize their pathway or work to fulfill regulatory requirement as a professional advise, but it is not your responsibility to ensure that the regulatory strategy is meeting requirements. (Unless stated otherwise in agreement.) 

I hope this helps.

Regards,

Rutvik Patel, MSRA

Is a contract manufacture who is providing a device design to customer requirements ever expected to ensure the client is meeting all of their regulatory requirements, say with registrations or submissions?  I'm thinking in terms of Clause 5.2 of ISO 13485, if I know a client's regulatory strategy is not meeting applicable regulatory requirements is it the contract manufacturer's responsibility to ensure they are aware of those requirements or that they are also fulfilling them?

Is a contract manufacture who is providing a device design to customer requirements ever expected to ensure the client is meeting all of their regulatory requirements, say with registrations or submissions?  I'm thinking in terms of Clause 5.2 of ISO 13485, if I know a client's regulatory strategy is not meeting applicable regulatory requirements is it the contract manufacturer's responsibility to ensure they are aware of those requirements or that they are also fulfilling them?

Hi Anon,

However, the regulatory approach/strategy and overall responsibility resides with the legal manufacturer of the final (finished) device.

If you can foresee that their approach is going to lead to unsuccessful submission, you should definitely bring this up to them and provide them with your thoughts. But if there is no one to hear you out, then it really does not affect your end of responsibilities. 

Is a contract manufacture who is providing a device design to customer requirements ever expected to ensure the client is meeting all of their regulatory requirements, say with registrations or submissions?  I'm thinking in terms of Clause 5.2 of ISO 13485, if I know a client's regulatory strategy is not meeting applicable regulatory requirements is it the contract manufacturer's responsibility to ensure they are aware of those requirements or that they are also fulfilling them?