EU Representation
Representing non-EU based manufacturers in a successful EU Market entry and safeguarding their future across the entire community.
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Ensuring compliance and registering products to be made available on the EU Market.
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For your products to legally enter the EU Market and continue to circulate, you must have valid documentation.
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Find your way through a complicated EU marketplace with the support of a professional.
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Back in 1988, our CEO Mr. Gideon Elkayam founded Obelis: a small, family-run business with a grand vision to “create compliance for safer markets”.
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Take the first step to a consulting career that helps build a safer Europe.
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We have provided compliance and consulting services for more than 3000 manufacturers in over 60 countries, helping them successfully introduce products to the European market.
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Our head office is in Brussels and we have a network of offices in 11 different countries including the US and Israel.
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An experienced EU compliance representative is just a call or meeting away…
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Obelis International Offices are independent partners who are able to provide our clients with solutions in other global markets of their choosing.
Learn MorePre-Market Notification

Notification for IVDs:
Manufacturers placing a device on the European market have to notify the Competent Authority of the EU Member State where they have their Registered address.
For non-EU manufacturers: Appoint a European Authorized Representative established within the European Union, which will notify the IVD towards the EU CA where they have their Registered Address.
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- Scope
- The Directive: IVDD 98/79/EEC
- Path to EU Market Entry
- Pre-Market Notification
- Notified Body
- Authorized Representative
- Risks of Non-Compliance
Any questions related to IVDD? Contact us now!
IVDD Inquiries