Overview of CER Reports
As per MDR – MEDDEV 2.7/1 Revision 4 guidelines, a Clinical Evaluation Report (CER) contains results of clinical evaluation and supporting clinical evidence to assess device conformity.
CER consists of scientific literature and analyzed clinical data, either from your device investigations or substantially equivalent devices, demonstrating that the device achieves its intended purpose without added risk to users or patients.
Following MEDDEV 2.7/1 Revision 4, there are 5 stages for clinical evaluation:
- Stage 0: Scoping, Plan Section 7 App. A3
- Stage 1: Identification of pertinent data Section 8 App. A4-A5
- Stage 2: Appraisal of pertinent data Section 9 App. A6
- Stage 3: Analysis of the Clinical Data Section 10 App A7-A8
- Stage 4: Clinical Evaluation Report, PMS/PMCF Plan Section 11 App. A9-A10
Expertise
- Identify, search, and analyze pertinent data (literature, clinical investigations, PMS, PMCF)
- Define device scope, intended usage, and therapeutic/diagnostic claims
- Analyze clinical data for safety, benefit/risk profile, performance, and side-effect acceptability
- Determine evaluation type based on available literature and clinical investigations
- Periodic update of CER per MDD/AIMDD/EU MDR guidelines
- Update CER continuously based on PMS, PMCF, PSUR, or vigilance activities
Advantages of CER Reports
- Cost-effective
- End-to-end regulatory consultation for 510(k), 513(g), CER, MDR, IVDR, and PER
- Qualified team with hands-on experience across all medical device categories
- Expert support for region-specific regulatory complexities
- Interactions with Health Authorities (HAs)
- Structured approach to ensure quick product launch or market access
