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Obelis — Your Consultant on EU Regulation
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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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EU Product Registration

Ensuring compliance and registering products to be made available on the EU Market.

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Technical 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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EU Consultancy, Legal & Training

Find your way through a complicated EU marketplace with the support of a professional.

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  • Healthcare & Medical Devices
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          • Industrial & Mechanical
            • Technology & Innovation

              About 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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              Careers at Obelis

              Take the first step to a consulting career that helps build a safer Europe.

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              The Team

              Meet the dynamic team creating compliance for safer European markets.

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              Testimonials

              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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              Get in Touch

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              Contact Us

              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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              International Representatives

              An experienced EU compliance representative is just a call or meeting away…

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              Obelis 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.

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              Obelis — Your Consultant on EU Regulation
              1. Home
              2. In-Vitro Diagnostics

              In-Vitro Diagnostics

              IVDR: MDCG Guidance on classification of in vitro diagnostic devices & proposed symbols for specific IVDs

              04 January 2021

              COVID-19 antibody ‘’self-tests” no longer banned in Belgium

              15 October 2020

              Guidance: Regulating medical devices from 1st January 2021 in Great Britain, Northern Ireland and the EU

              09 September 2020

              MedTech Europe raises industry concerns over the successful transition to the new IVDR

              03 September 2020

              Personal protective Equipment and Medical Devices in the Covid-19 context –how can they be lawfully placed on the EU market?

              06 July 2020

              National MDR implementation – Germany’s establishment of NAKI

              05 July 2020

              UK’s new dedicated Yellow Card reporting site

              22 June 2020

              In Vitro Diagnostic Devices: main steps to compliance and frequently asked questions

              02 June 2020

              EU Commission guidelines on Covid-19 tests’ performance

              01 June 2020

              New 2020 lists of harmonised standards for medical devices made available

              22 April 2020

              Conformity assessment procedures for COVID-19 protective equipment

              22 April 2020

              ISO 20916 - IVDs - Clinical performance studies using specimens from human subjects - Good study practice

              20 December 2019
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