Clinical Evaluation of Medical Devices – Foundation Course

Increased safety by the clinical evaluation of medical devices

Increased safety by the clinical evaluation of medical devices

Course Description

Clinical evidence plays an important role in the conformity assessment procedure for medical devices. No further approval will be possible in Europe without sufficient clinical data to prove the safety, performance and benefit of a medical device. This seminar will provide you with the basic requirements of the European laws and guidelines for clinical evaluation and their implementation in the context of the conformity assessment procedure for medical devices, covering the entire product life cycle.

That includes the general procedure of a clinical evaluation and the required contents of documents to be prepared, such as the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER). Changes resulting from the Medical Device Regulation (2017/745, MDR) for clinical evaluation are highlighted. In addition, the importance of clinical evaluation in the post-market surveillance (PMS) phase, including clinical follow-up (PMCF) will be discussed. The experience gained in the cooperation with notified bodies can help to meet the requirements more easily and avoid mistakes.

Course Contents

  • Importance and types of clinical data for approval and marketing of medical devices 
  • Basic requirements of the European laws and guidelines for clinical evaluation
  • Procedure and documentation of a clinical evaluation according to MDR and relevant guidelines (MDCG)
  • Contents of the Clinical Evaluation Plan and Clinical Evaluation Reports 
  • Different types of clinical data for medical devices and their sources
  • Start by setting up a clinical strategy to determine the route for clinical evaluation
  • Weighing the need for clinical investigations for conformity assessment procedures 
  • Evaluate equivalence of other devices
  • Conduct literature search and evaluate and analyze publications. 
  • Connection to risk analysis in the evaluation of clinical data for medical devices and benefit-risk assessment. 
  • Continuous updating of the clinical evaluation in connection with the post-market surveillance (PMS) system

Who Should Attend

  • Employees and consultants in:
    • Regulatory affairs
    • Quality assurance/management
    • Research and development
    • Clinical affairs and post-market surveillance
    • Product management
  • Competent authorities
  • PRRC
  • Sponsor

Course Objectives

  • You will acquire know-how for the targeted identification and provision of required clinical data for medical devices.
  • You will be able to successfully clinically evaluate your medical device.
  • You will implement regulatory requirements and comply with official guidelines regarding the clinical evaluation of medical devices.

Requirements

No requirements are necessary. 

Methodology

This seminar addresses internationally valid standards. The contents of the seminar correspond to the current status of the revision/harmonization.

 

Next Steps

Site Selector