Overview Of CER Reports
As per the new MDR – MEDDEV 2.7/1 Revision 4 guidelines. A Clinical Evaluation Report (CER Reports) contains the results of clinical evaluation and the clinical evidence on which it is based, which will support the assessment of the conformity of the device.
A CER (Clinical Evaluation Report) consists of scientific literature and analyzed clinical data that was collected either from a clinical investigation of your device, or the results of other studies on substantially equivalent devices. The CER demonstrates that your device achieves its intended purpose without exposing users and patients to further risk.
Referring to the new MDR – MEDDEV 2.7/1 Revision 4, there are 4 different stages to perform a clinical evaluation:
Expertise
- Identify, search, analyze Pertinent Data (literature’s, Clinical investigations, PMS, PMCF data)
- Defining the scope of the device, its intended usage and therapeutic/diagnostic claims
- Analysis of Clinical Data (Based on Safety, Acceptable Benefit/Risk Profile, Performance, Acceptability of Side-Effects)
- Device under Evaluation (Type of Evaluation -Based on available scientific literature’s, Clinical investigations etc.
- Periodic update of existing CER as per MDD/AIMDD/EU MDR guideline.
- Updating of CER, as per be continually updated per Post Market Surveillance [PMS] and PMCF or Periodic Safety Update Report [PSUR] or Vigilance activities
Advantages Of CER Reports
- Cost-effective
- End-to-end Regulatory consultation, of 510(k) Submission Process Consulting, 513(g) Submission Process Consulting, Clinical Evaluation Report (CER), Medical Devices Regulation (MDR), In Vitro Diagnostic Regulation (IVDR) and Performance Evaluation Report (PER)
- Qualified team of experts with hands-on experience across all categories of Medical Devices.
- Expert support for region-specific Regulatory complexities
- Interactions with Health Authorities (HAs)
- Structured approach to ensure quick product launch or market access
