Clinical Evaluation Plan and Report (CEP/CER) Services
We understand the critical importance of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) in the life cycle of medical devices. These evaluations are not just a regulatory requirement; they are a cornerstone for ensuring the safety and performance of medical devices in real-world applications.
Our CEP/CER services are designed to assist manufacturers in meeting the stringent requirements of the European Union Medical Device Regulation (EU MDR), UK MDR, and other global standards.
A Clinical Evaluation is a systematic, planned process to generate, collect, analyse, and assess clinical data about a medical device. It verifies the device’s safety, performance, and clinical benefits when used as intended by the manufacturer.
As outlined in MDR Article 2(44), the evaluation encompasses:
- Reviewing existing clinical data.
- Generating new data via clinical investigations.
- Appraising the clinical data to validate safety and performance.
- Documenting findings in a Clinical Evaluation Report (CER).
This continuous process plays a vital role in addressing new risks, trends, or regulatory updates throughout the product’s lifecycle.
A Clinical Evaluation is essential at various stages, including:
- Design and Development: Identifying gaps and generating required clinical data during the initial stages.
- Initial CE Marking: Achieving certification approval from the Notified Body.
- CE Certification Renewal: Demonstrating ongoing compliance for certification renewals.
- New Post-Market Surveillance (PMS) Data: Addressing significant PMS findings that impact the benefit-risk profile.
- Regulatory or Notified Body Requests: Ensuring readiness for surveillance audits or specific requests.
Our CEP/CER Services
Clinical Evaluation Plan (CEP)
The CEP is the foundation of a robust clinical evaluation. It includes:
- Clinical development strategy.
- Device description and intended use.
- State-of-the-art analysis.
- Post-market clinical follow-up (PMCF) strategies.
- Systematic literature search protocol
Clinical Evaluation Report (CER)
The CER compiles all relevant clinical data to demonstrate safety and performance. It includes:
- Clinical Evidence from literature reviews, clinical investigations, and PMS data.
- Comprehensive benefit-risk analysis.
- Evaluation against Essential Requirements or General Safety and Performance Requirements (GSPR).
Why Choose Cormica for CEP/CER?
Our team delivers tailored solutions based on device risk classifications:
- Class I & IIa Devices: Updates every 2-5 years or as required or based on significant PMS data and/or CE certificate renewals.
- Class IIb & III Devices: Annual updates for high-risk and implantable devices, integrating the latest PMS and PMCF data.
EU MDR & MEDDEV 2.7.1 Rev 4 standard CEP/CER templates
- Gap Analysis for the existing manufacturer templates
- Cormica CEP/CER templates to ensure that your submissions are in line with regulatory requirements and guidelines.
Fast Turnaround Times
- Class I & IIa Devices: CEP in 2 weeks, CER in 4 weeks.
- Class IIb & III Devices: CEP in 4 weeks, CER in 3-4 months.