Hi All,
I work for a UK medical device design and manufacturing company. We have just purchased a medical device company based in Europe who will undergo the change of name in December. Based at the site in Europe is a R&D function, a Quality function, HR, Sales and a Regulatory Officer, and the site is certified to ISO 13485. At present all these functions are associated with the sub-contract manufactured product we acquired as a part of the purchase, and not any of the product currently manufactured in the UK. However, we are in the process of integration with departments from both sites already interacting, and looking to have a shared business management system that will be accessible to both sites and consist of group procedures as well as site specific by the end of next year.
Post-Brexit could we use this site as the EU Authorised Representative for the UK manufactured product as it stands, and if not what would we need to do quickly to enable this. Also, as we would be the same company, I'm assuming that the address of the EU site will need to appear on the label of the product as the EU Authorised Representative.
JoCam
I work for a UK medical device design and manufacturing company. We have just purchased a medical device company based in Europe who will undergo the change of name in December. Based at the site in Europe is a R&D function, a Quality function, HR, Sales and a Regulatory Officer, and the site is certified to ISO 13485. At present all these functions are associated with the sub-contract manufactured product we acquired as a part of the purchase, and not any of the product currently manufactured in the UK. However, we are in the process of integration with departments from both sites already interacting, and looking to have a shared business management system that will be accessible to both sites and consist of group procedures as well as site specific by the end of next year.
Post-Brexit could we use this site as the EU Authorised Representative for the UK manufactured product as it stands, and if not what would we need to do quickly to enable this. Also, as we would be the same company, I'm assuming that the address of the EU site will need to appear on the label of the product as the EU Authorised Representative.
JoCam
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