Related Experiment Video
Updated: Aug 5, 2026

E-Patient Counseling Trial (E-PACO): Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
Published on: August 1, 2019
Insights from expert panels on the EU clinical evaluation consultation procedure
Hilde Bastaerts1, Francesca Romana Del Vecchio1, Miguel Antunes1
1Expert Panels and Groups Office, Committees and Quality Assurance Department, European Medicines Agency, Amsterdam, The Netherlands.
Background:
The Clinical Evaluation Consultation Procedure (CECP) under the EU Medical Device Regulation aims to strengthen and harmonize the assessment of high-risk medical devices. This review summarizes early insights from expert panels to support improved clinical evaluation practices.
Research Design And Methods:
This review analyses 34 expert panel opinions derived from 281 CECP submissions between April 2021 and December 2025. Statements from opinions were systematically extracted, de-duplicated, and grouped into thematic categories, with independent review and validation. The analysis focuses on common challenges found during the consultation procedure of the expert panels on the content of the clinical assessment in relation to clinical evidence, benefit-risk assessment, intended purpose alignment, and post-market clinical follow-up planning.
Results:
Expert panel findings highlight recurrent issues in the sufficiency, consistency, and transparency of clinical evidence, underscoring the need for improved standardization and clearer guidance.
Conclusions:
Strengthening documentation quality and alignment across stakeholders will enhance the robustness, efficiency, and predictability of conformity assessments for high-risk medical devices.
Related Concept Videos
Clinical Trials
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview
Preclinical Development: Overview
Clinically Relevant Drug Product Specifications: Methods of Establishment
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Ethical Dilemmas II
