CEpartner4U
Your partner or consultant for the CE Marking of medical devices

European Authorized Representative and Consulting services for manufacturers of Medical Devices

Why CEpartner4U

CEpartner4U serves as consultant and Authorized Representative (AR or EC Rep) under the European Medical Device Directives for hundreds of manufacturers from all over the world. From longstanding experience, we understand the dynamics of CE marking. As Authorized Representative, we consider it our privilege and duty to monitor your regulatory position in Europe.

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Authorized Rep.

All non-European manufacturers must appoint an Authorized Representative within the European Union. As Authorized Representative we are your interface with the EU Competent Authorities. In addition we offer affordable consultancy to assist you with building and maintaining your technical files, focused on minimizing the documentation.

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Quality Management

Quality is a verb. CEpartner4U can assist you with implementing and sustaining your quality management system according to ISO 13485. The implementation of a quality management system is one of the requirements for manufacturers of higher risk class devices. ISO 13485 is globally accepted as the standard for organisations involved in the medical device lifecycle.

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Services

Our services regarding medical devices include:

  • Authorized Representative service
  • Registration with EU-Authority
  • Certificate of Free Sales
  • CE-marking consultancy
  • Technical file preparation
  • Notified Body guidance
  • Clinical trial guidance
  • Quality system implementation

CE-marking

All medical devices which are on the European Market needs to be CE-marked. By placing the CE-mark on a device, the manufacturer confirms that the product meets the requirements of the European Medical Device Directives (MDD 93/42/EEC, IVDD 98/79/EC and AIMDD 90/385/EEC).
The manufacturer, is responsible for the safety and efficacy of these devices.

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Notified Body

Assessment for medium / high risk products:

A Notified Body assesses the conformity for medium and high risk medical devices (MDD: Class I sterile / measurement, Class IIa, IIb or III; IVDD: self-test, List A, List B; AIMDD: all). After the assessment, a CE-certificate will be issued to the manufacturer. The Notified Body will audit the manufacturer annually. Periodically, the Notified Body will perform unannounced audits. In duly substantiated cases, also the subcontractors or parties further in the supply chain can be subject to unannounced audits.