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Posted by Theresa on September 23, 2024 at 4:07am 0 Comments 0 Likes
Posted by se on September 23, 2024 at 4:07am 0 Comments 0 Likes
The European Authorized Representative is represented on the medical device label with a logo, as seen below. Along with the logo, the EAR name, address, and contact information must be printed on the Declaration of Conformity (DOC), Technical Documentation, and in the Instructions for Use (IFU). To appoint an EU Rep / EC Rep, the manufacturer must sign a contract outlining each party’s rights and responsibilities, as well as the general way of collaboration and costs.
According to the EU MDR 2017/745 and EU IVDR 2017/746, EU Representative is mandatory for Non-European manufacturers wishing to sell medical devices and (IVDs) on the European market. The European Authorized Representative is a natural or one that is legalized and established within the EU, who has received and accepted a written mandate or decree from the manufacturer located outside of the European Union.
This can be a great way for international companies to sell their products in Europe, as it helps streamline the process of getting your product approved for sale by European regulators.
Responsibilities of EU Representative
According to Article II of the EU MDR and IVDR, the following are the roles and responsibilities of the European Authorized Representative.
Benefits of working with I3CGLOBAL and its associates
Whether you need a company to carry out regulatory matters, market in your territory, or provide new kinds of expertise or technical advantage, we'll be there for you. With I3CGLOBAL as your partner, you can expect us to be responsive to your needs at all times.
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