Clinical Evaluation Report (CER)
In present regulatory scenario, CER - Clinical evaluation reports have grabbed all the attention of device manufacturers. Medical devices which are being sold in Europe, is demanding an up-to-date CER as part of its product technical dossier, irrespective of its classification which is to be accompanied even during CE marking. According to the EU, a CER “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.
CER provides key evidence in terms of safety, performance and compliance information even for Class I devices. Medical Device manufacturers are therefore to be prepared for regular or unannounced audit by Notified bodies. This means that the device manufacturers may need to be cautious while selecting the scientific author for CER preparation.
As a solution provider MakroCare offers the right search strategy, optimum monitoring and preparedness with meaningful reports, for Medical Device and In-Vitro Diagnostic manufacturers. Important to note is that a methodical collection of information and critical analysis is the absolute requirement for all risk classes of Medical Devices and even Class I.
Critical challenges are mainly:
- Managing workload and optimum monitoring of information sources for legacy products
- Critical challenges requiring identification of experts for the right point of view during analyzing clinical information.
- Customized support for all - large, medium and small Enterprises.
- Dedicated team of 40+ experienced Information specialist, medical/technical writer and statisticians
- Experienced in collating important information from various publications as well as multiple source reports like safety, complaints, marketing, change management, clinical reports etc.,
- Experienced with all major literature search referring to protocols, reports, equivalent devices etc,
- Referring to relevant sections of the relevant guidelines
- Identification, thorough Review, right interpretation, appraisal and analysis of clinical data
- Writing CER in suggested format MEDDEV 2.7.1 r3 to avoid authority rejection.
- Medical specialist to oversee & guide on critical requirements on end to end deliverables
- Direct time and cost efficiencies
MakroCare will assist you in completion of your CER compiling the data in an efficient, compliant, user-friendly format following regulatory guidelines.