M
missjenny
Hello,
If the legal manufacturer of a medical device declares for bankruptcy, is their CE certificate still valid or does it become obsolete?
In this situation, could the contract manufacturer, who actually makes the product, continue manufacturing the product and ship them out to the existing distributors in the EU as they had done in the past or would this be viewed as illegal or against directives/regulations in the EU?
This would not be something that would be continued for years, but just for three or four months as payment has already been received for the production of a certain quantity of the products.
It would be great if you could share your opinions based on experience or common sense or even better if you could point me to a section of a guideline or directive, that would be great.
If the legal manufacturer of a medical device declares for bankruptcy, is their CE certificate still valid or does it become obsolete?
In this situation, could the contract manufacturer, who actually makes the product, continue manufacturing the product and ship them out to the existing distributors in the EU as they had done in the past or would this be viewed as illegal or against directives/regulations in the EU?
This would not be something that would be continued for years, but just for three or four months as payment has already been received for the production of a certain quantity of the products.
It would be great if you could share your opinions based on experience or common sense or even better if you could point me to a section of a guideline or directive, that would be great.