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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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                    About Us

                    Largest center in Europe for CE Marking & European Representative Services.

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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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                    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

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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 European Regulation
                    1. Home
                    2. In-Vitro Diagnostics

                    In-Vitro Diagnostics

                    Obelis Roundtable on IVDR: How to get ready?

                    13 April 2022

                    IVDR: What are EU Reference Laboratories (EURLs)?

                    24 February 2022

                    IVDR: Clinical Evidence Requirements for Manufacturers

                    24 February 2022

                    Use of Octylphenol ethoxylate (Triton-X-100) banned in medical devices and IVDs

                    27 October 2021

                    French CA issues procedure deal with risks of rupture of essential medical devices and IVDs.

                    30 September 2021

                    COVID self-test in Belgium can be sold freely as of the 1st of July 2021

                    25 August 2021

                    COVID self-tests in Belgium: Conditions and approval process

                    23 April 2021

                    EUDAMED

                    20 April 2021

                    State of the art of COVID-19 rapid antibody tests

                    23 March 2021

                    COVID-19: France bans urine self-tests and opens the possibility for antigen self-tests

                    23 March 2021

                    European preparedness and response to the COVID-19: a common list of rapid antigen tests

                    23 March 2021

                    Covid-19 IVD Test Kits – Swab Compliance

                    04 March 2021
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