Clinical Evaluation Training within the Scope of (EU) 2017/745 Medical Device Regulation (MDR)

All new or existing medical devices placed on the market within the European Union must have an up-to-date Clinical Evaluation Report as part of the Technical Dossier. Conceptual confusion continues in the industry regarding the basic requirements and best practices regarding the creation and updating of these reports. With the implementation of the (EU) 2017/745 Medical Device Directive, it is important to review clinical evaluation reports in terms of new requirements, conduct gap analysis and provide supporting clinical data before appropriate planning and certification process within the scope of MDR.

Purpose of Training:

Medical Devices 2017/745 training is designed to provide you with an understanding of the clinical evaluation process, including the legal requirements for clinical evaluation, the principles of clinical evaluation, and details of how these are conducted and documented. The practical activities included in the training provide you with the opportunity to apply your skills to conduct a clinical assessment in your company upon completion of the training.

Content of the Training:

What is Clinical Evaluation?

Qualifications of Personnel Conducting the Clinical Evaluation Process

Changes within the Scope of MDR

SSCP

Clinical Trial Requirements

Clinical Consultation Processes

Definitions in Clinical Evaluation Processes

Clinical Data Sources

Equivalence Requirements

Evaluation of Clinical Data

Analysis of Clinical Data

Clinical Evaluation Report

Risk/Benefit Analysis and Evaluation of Total Remaining Risk

Clinical Evaluation Update

Sufficient Clinical Data

Clinical Study on Medical Devices in General Terms

Practical Activities

Education Activity Questions

Who Should Participate:

• Licensing Experts
• Medical Device R&D Engineers
• Medical Device Manufacturers
• Internal and External Auditors
• Quality Managers
• Development, Production and Marketing Managers
• Clinical Experts
• People who want to improve themselves in clinical evaluation
• Consultants

Benefits of Education:

Ability to identify clinical evaluation process changes within the scope of MDR

Ability to determine the basic requirements in clinical evaluation processes according to MDR, MEDDEV 2.7/1 Revision 4 and relevant MDCG guidelines.

Ability to explain the principles of clinical evaluation

Ability to outline the stages of the clinical evaluation process and documentation requirements

Being able to explain the concept of equivalence

Ability to determine when a clinical trial for a medical device is necessary  Ability to define the requirements of a clinical evaluation report

Reference Sources:

(EU) 2017/745 Medical Device Regulation

MDCG Guides

Meddev 2.7/1 Rev4

Tuition Fee:

Please send an e-mail to info@udem.com.tr to get information about training fees. If there are 3 or more participants from the same company/institution, a 10% discount will be given. A 10% discount will be provided for participants who register early.

Education Record:

To complete the training registration, please fill out the training registration form in the link below and send an e-mail to info@udem.com.tr.

Detailed Information:

For detailed information about the training, you can contact us through the following communication channels.

Tel: +90 312 4430390

Mail: info@udem.com.tr