Online EU MDR 2017 745 Practitioner Training | CQI & IRCA Certified

eLearning Modules

• History of the EU MDR
• Purpose of the EU MDR
• Structure of EU MDR
• Key Terminology
• Key EU MDR changes
• EU MDR Timelines for transition
• What is a device?
• Devices in scope
• Devices out of scope
• Non-Medical devices
• Overview of Chapter II
• Articles 5-9
• Economic Operator & PRRC Responsibilities
• Articles 16-24
• Overview of Annex VIII
• Class Types
• Classification Rules
• Overview of Conformity Annexes
• Annex IX
• Annex X
• Annex XI
• Custom Made Devices
• Notified Body Articles & Annexes
• Overview of Annex I
• Chapter I General Requirements
• Risk Management (ISO 14971)
• Chapter II Design & Manufacture
• Chapter III Device Information
• Overview of the Clinical Evaluation requirements including Article 61-62 and Annex XIV
• Overview of PMS Articles 83-86
• Overview of Vigilance Articles 87-89
• Annex II and Annex III Technical documentation
• Unique Device Identification (Annex VI)
• UDI Timelines
• Overview of EUDAMED

On completion of this Online EU MDR Practitioner Training, successful Learners will have the knowledge needed to:

1. Explain the history, purpose, and structure of the EU MDR, and the key terminology used throughout the regulation
2. Identify the types of devices covered by the EU MDR and the rules for classifying these devices
3. Describe the obligations of the economic operators and the PRRC
4. Describe the General Safety & Performance Requirements and the key features of a risk management system based on ISO 14971
5. Describe the contents of the Technical Documentation and the requirements for Post Market Surveillance, Vigilance, and Clinical Data
6. Explain the Unique Device Identifier requirements and the relationship with EUDAMED

• Quality assurance professionals
• Quality Engineers
• Research and design Engineers
• Internal Auditors
• Quality Managers
• Manufacturing Engineers
• Regulatory professionals

Before completing this course, each Learner should have the following prior knowledge:

ISO 13485

•  Knowledge of the requirements of ISO 13485, which may be gained by completing a CQI and IRCA Certified MD-QMS ISO 13485 2016 Foundation (FD132) training course or equivalent.

Medical Device Quality Management Systems

Knowledge of the following quality management principles and concepts:

• The relationship between ISO 13485 and the EU MDR 2017 745
• Commonly used quality management terms and definitions within ISO 13485 and ISO 9000
• A working knowledge of risk management principles related to the design of a medical device, through ISO 14971

EU MDR Practitioner Training Assessment Methodology

In order to successfully complete this course, each Learner will need to:

• Complete the eLearning modules and obtain 70% or higher in the final assessments (MCQ-based) within the 90-day course license

EU MDR Practitioner Training Certification

Our Comprehensive EU MDR 2017/745 Practitioner Training Course is CQI & IRCA Certified (No. 2378). Successful completion will entitle each Learner to receive a digital Certificate of Achievement.

There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read full technology requirements

In registering for this course, each Learner and/or Customer expressly acknowledges that they have read, fully understood and agreed to be bound by all of Comply Guru’s terms & conditions, including additional licensing agreement. The terms & conditions & licensing agreement can be read here.