Medical Device CE marking

For over 20 years, CEpartner4U has been a valued partner of hundreds of organizations worldwide. Our services range from regulatory strategy and compliance to clinical evaluation, authorized representation (EC REP), and training.

To place a medical device on the European market, all non-EU manufacturers must appoint an Authorized Representative (AR or EC Rep) within the Union.
As Authorized Representative, CEpartner4U is your interface with the EU Competent Authorities.

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CEpartner4U supports you and your stakeholders with the interpretation and application of the European Regulations for medical devices, from self-supporting tools to extensive consultancy.


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CEpartner4U frequently organizes seminars and training, addressing a variety of topics including CE marking, quality management, device classification, risk management, and strategy.

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Our services: