Clinical Evaluation Reports

A Clinical Evaluation Report (CER) is a critical technical document, required by all medical device companies that want to sell or distribute products in Europe. This is a key documentation that demonstrates compliance with the applicable regulatory standards and expectations.

The regulatory expectations from the MEDDEV Rev4 were significantly increased, and the introduction of the Medical Device Regulation (MDR) is further elevating the expectations for clinical evidence, post-market clinical follow ups, and technical requirements.

Evnia has a core competence in developing compliant Clinical Evaluation Reports, with documented success, having completed more than 245 CERs during the last 5 years.

Evnia develops and maintains compliant Clinical Evaluation Reports and its supporting documentation for Medical Devices of all classes.

Clinical Evaluation Continuity

Evnia offers centralised CER services that include a cross-functional team:

  • Medical Writers
  • Medical Doctors
  • Usability & Validation Engineers
  • Biocompatibility Experts

This way, we ensure you get the most comprehensive, one-stop-shop service on the market that includes:

  • MDD & MDR readiness for Class I through to Class III devices
  • Documentation update to MDR standard
  • In-house clinical experts
  • Regulatory know-how
  • Built-in quality control
  • PMCF plans & reports

Contact us today by going to our contact page or call us at +45 32 74 53 97 to evaluate your needs towards achieving regulatory compliance.

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