Medical device CE marking

Medical Device CE marking

For more than 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.


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CEpartner4U as Representative

All non-EU manufacturers must appoint an Authorized Representative (AR or EC Rep) within the Union. As AR, 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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CEpartner is there 4U to train you on regulatory affairs, quality management and clinical evaluation. We can arrange for on-site training or by video conference.