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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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 MoreMedical Device Directive

Key Facts:
- After May 26, 2020 the Medical Device Directive will be fully replaced by the Medical Device Regulation
- MDD I manufacturers and MDD I(s/m), IIa, IIb or III who do not already possess a CE Certificate with an expiration date beyond May 26, 2020 are obligated to comply by this deadline
- EUDAMED is scheduled to become operational for Notification per the MDR by March 2020
Learn More:
- Scope
- Classification
- The Directive: MDD 93/42/EEC
- Technical File
- Notified Body under the MDD
- Authorized Representatives under the MDD
- Custom Made Medical Devices
- Clinical Investigation
- Kits
- Risks of Non-Compliance
With the Medical Device Regulation transition well underway, be sure to learn about the upgraded requirements in order to comply by the May 2020 deadline.
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