Elsmaruser2207
Registered
Hello there,
Hope you all are safe and healthy!
I have a question regarding opening new markets. Our company (established in The Netherlands) manufactures a class I medical device (actually an accessory of a medical device). We are MDR compliant, which means our customers/distributors may distribute our products within the European Market (if mutually agreed upon a distribution agreement). However, one of our (distributing) customers wants to sell our products in new markets outside the European Union. Opening new markets brings us new opportunities, however since we are not familiar with the legislation in those other countries, we are precautions with this. We are a small company and have no resources department.
We therefore only want to agree on selling our products outside the EU if the customer will be fully responsible for these Products (including all quality system and regulatory requirements).
Our products are delivered with CE mark for EU compliancy and also bear our name as legal manufacturer. However we want the customer to be the de facto legal manufacuturer for the new markets outside the EU. Is this even possible if our name is on the products? If not, how can we best tackle this? Please let me know!
Hope you all are safe and healthy!
I have a question regarding opening new markets. Our company (established in The Netherlands) manufactures a class I medical device (actually an accessory of a medical device). We are MDR compliant, which means our customers/distributors may distribute our products within the European Market (if mutually agreed upon a distribution agreement). However, one of our (distributing) customers wants to sell our products in new markets outside the European Union. Opening new markets brings us new opportunities, however since we are not familiar with the legislation in those other countries, we are precautions with this. We are a small company and have no resources department.
We therefore only want to agree on selling our products outside the EU if the customer will be fully responsible for these Products (including all quality system and regulatory requirements).
Our products are delivered with CE mark for EU compliancy and also bear our name as legal manufacturer. However we want the customer to be the de facto legal manufacuturer for the new markets outside the EU. Is this even possible if our name is on the products? If not, how can we best tackle this? Please let me know!