Consulting, development, coordination. Licensing a medical device does not have to be difficult. Read more in the sidebar information below.
You may only one Authorized Representative in the entire European Union; whereas may have many distributors and/or sales agents. The Authorized Representative usually does NOT involve itself in the distribution and/or sales products as the importers/distributors usually does.Most importers/distributors speciialise in marketing and sales, but are not familiar with the complicated CE Marking issues. An Authorized Representative represents the non-EU-manufacturer and deals with the CE Marking vigilance authorities from the 27 EU + 3 EFTA * Member States. They may call the Authorized Representative for CE Marking vigilance at any time and the Representative must respond immediately and properly within the permitted time.According to the council directive 93/42/EEC concerning medical devices for non-European manufactures an authorized representative is mandatory.
„Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorized representative in the European Union. For devices referred to in the first subparagraph of paragraph 1, the authorized representative shall inform the competent authority of the Member State in which he has his registered place of business of the details referred to in paragraph 1.“
Keep your eyes on the ball! The complicated process of medical device licensing and registration can be a confusing maze of procedures. National licensing is different from international licensing; re-engineering is different from new-product licensing. It's a cost-effective and effortless solution from start to finish, so you can do what you do best. Stay focused and let us take care of the rest.
Enter the european market with EUROM
We provide support with getting listed in the technical aid index and extensive CE-certification maintenance services, in addition to introducing quality management systems.
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According to the council directive 93/42/EEC concerning medical devices for non-European manufactures an authorized representative is mandatory.
EUROM - your authorised representative.
We specialize in registration and licensing but understand that each submission is unique. Our expertise is knowing what is right for each client and employ optimized methods.
Consulting, development, coordination.
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