Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device. Clinical Evaluation Reports (CERs) document the clinical evidence that supports a medical device licensing application.
CER needs a careful plan, to ensure all important aspects are covered for the clinical evaluation, which is regarded as "Stage 0" in the MedDev 2.7/1 revision 4. Identifying clinical data from the literature search is "Stage 1" to compile a CER. Literature screening and selection is then conducted as "Stage 2" in terms of its suitability, applicability, quality and clinical significance. Publications with relevant, usable data on device performance and safety are included in the clinical evaluation analysis. The literature summary is incorporated into the CER, together with other sections to form a complete CER report.
Europe's Medical Device Regulation (EU MDR 2017/745) is a European Union law about medical devices. The MDR imposes strict requirements for the content of CER, demanding more clinical data during the whole life-cycle of the marketed products. These requirements are essentially those described in the EU guideline.
- 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. These data must be collected, appraised, and analyzed in a structured way.
- 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.
- The CER is granted initial market approval (the CE-mark) after being reviewed by the Notified Body (NB), or regularly updated to enable the medical device to remain on the market after a successful application.
MedTrans' medical translators and writers with their substantial and longstanding experience in translating and writing regulatory documents, as well as awareness of the changing regulatory landscape, 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.
With streamlined processes, we deliver CERs of specified languages as a complete package. Contact us to discuss your multilingual CER translation and writing needs.
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