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:

  1. Design and Development: Identifying gaps and generating required clinical data during the initial stages.
  2. Initial CE Marking: Achieving certification approval from the Notified Body.
  3. CE Certification Renewal: Demonstrating ongoing compliance for certification renewals.
  4. New Post-Market Surveillance (PMS) Data: Addressing significant PMS findings that impact the benefit-risk profile.
  5. Regulatory or Notified Body Requests: Ensuring readiness for surveillance audits or specific requests.
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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).
Clinical Evaluation Plan (CEP)
Clinical Evaluation Plan (CEP)

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.

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