Hello,
Our company has quality agreements in place with distributors of our medical device with basic requirements for quality, notification and reporting. Examples of some of the requirements:
The distributor should be registered as such in his own country. We have never checked or required this from them since this is his own obligation to perform when distributing medical devices. However, with IVDR's liability of all economic operators in the chain, the question arose if we should put this requirement in Quality agreement.
I still don't think that the distributor's failure to register locally as a medical device distributor should be our fault.
What are your thoughts on this? Do you think we should include this requirement in the Quality agreement or leave it as it is since it is the distributor's responsibility to follow local requirements?
Our company has quality agreements in place with distributors of our medical device with basic requirements for quality, notification and reporting. Examples of some of the requirements:
- ensure that the Product is stored and shipped in accordance with recommended storage conditions,
- maintain and supply upon request documentation that supports the recommended storage and transportation conditions plus re-evaluation or expiry dates,
- all non-conformance should be investigated. Where applicable, this includes the identification of the root cause, a risk analysis of the actions taken for the correction of the problem, prevention of future occurrence, and the formal conclusion by the Partner’s Quality Assurance. If an investigation reveals that there is an impact on the Product received by the end user, the Partner shall inform the Company without unreasonable delay,
The distributor should be registered as such in his own country. We have never checked or required this from them since this is his own obligation to perform when distributing medical devices. However, with IVDR's liability of all economic operators in the chain, the question arose if we should put this requirement in Quality agreement.
I still don't think that the distributor's failure to register locally as a medical device distributor should be our fault.
What are your thoughts on this? Do you think we should include this requirement in the Quality agreement or leave it as it is since it is the distributor's responsibility to follow local requirements?