Clinical Evaluation Report (CER)

  • Clinical Evaluation Reports (CERs) document the clinical evidence that supports a medical device licensing application.
  • Europe’s Medical Device Regulation (MDR) (EU 2017/745) imposes strict requirements for the content of Clinical Evaluation Reports and these are essentially those described in the EU guideline, MedDev 2.7/1 revision 4 (EU-2016).
  • These include an expert and comprehensive review of clinical data derived from clinical investigations of the performance and safety of the device, and/or the results of studies on equivalent devices.
  • A further requirement is the inclusion of regularly updated systematic literature reviews of the relevant clinical setting (State of the Art) and of published reports relevant for assessing the device`s performance and safety.
  • After a successful application, the CER is regularly updated to enable the medical device to remain on the market.
  • Trilogy´s medical writers, with their substantial and longstanding experience in writing regulatory documents, will reduce the challenge of meeting the regulatory demands by producing a clear and concise document that effectively communicates the relevant data to the regulators.
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“...the person who was assigned to work on a CER for us is fabulous from the feedback I’ve received. My group is beyond thrilled with his expertise, guidance, and communication style. I’m so glad we reached out to you for this document, which is our first CER so far...”