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.
Learn MoreTechnical Documentation Review & EU Submissions
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.
Learn MoreAbout Us
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…
Learn MoreObelis International Offices (OIO) Network
Obelis International Offices are independent partners who are able to provide our clients with solutions in other global markets of their choosing.
Learn MoreIn-Vitro Diagnostic Medical Device Regulation

Key Facts:
- Expanded scope to include companion diagnostics
- Classification systems has been altered to risk-based system to more closely match other international markets
- All non-EU based manufacturers are obligated to appoint an Authorized Representative
Presenting MDlaw.eu:
The most extensive and up-to-date database on European IVDR laws. Have a look!
Learn More:
- Scope
- The Regulation: IVDR 2017/746/EU
- Classification
- Technical Documentation
- Path to EU Market Entry: Conformity Assessment Procedures
- Notified Bodies under the IVDR
- Authorized Representatives under the IVDR
- Clinical Evidence and Performance Evaluation
- Clinical Performance Studies
- Person Responsible for Regulatory Compliance
Other questions related to IVDR? Contact us now!
IVDR Inquiries