MMD-114    Understanding the EU Medical Device Regulation 2017/745

• Overview
• Course Objectives
• Course Content
• For Whom
• Schedule and Hours

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This course is designed to provide participants with the knowledge on medical device market access into the Union. Personnel responsible for quality systems for medical device manufacturers will benefit from this course. Participants will gain an overview of the requirements of the CE Marking approach and the EU Medical Device Regulations as well as the key differences from the EU Medical Device Directive.

​Participants will be led by an experienced trainer who, in addition to being a Product Assessor and CE Marking auditor, has three decades of assessment, training, and quality assurance as well as management system development experience. Participants will engage in lectures including exercises in harmonizing these requirements and those of the IMDRF with respect to medical devices regulatory compliance as well as failures encountered by manufacturers in attempting conformity assessment.

Upon completion this programme, participants are able to:

• Understand the CE Marking process and its importance for medical device market access.
• Comprehend the key requirements and changes introduced by the EU Medical Device Regulations (2017/745).
• Identify the risk classification and general principles of safety and performance.
• Learn about the role of standards and the significance of clinical data in regulatory compliance.
• Gain insights into post-market activities and labelling requirements for medical devices.

• Section 1: CE Marking Process
• Section 2: EU Regulations – Medical Devices and In Vitro Diagnostic Devices
• Section 3: Latest Amendments to Regulations (EU) 2017/745
• Section 4: Risk Classification
• Section 5: General Principles of Safety & Performance
• Section 6: Role of Standards
• Section 7: Clinical Data
• Section 8: Labelling Requirements
• Section 9: Post Market Activities

This course is designed for :

• Regulatory and quality staff responsible for preparing for or hosting CE Marking audits.
• Organizations wishing to place their medical devices in EU, EUCU, EFTA markets, MRA jurisdictions, and/or Turkey.
• Those who need an understanding of the EU CE Marking approach for medical devices.

This is a ​2 to 3-days programme.
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This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.

We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
​All of our training modules are claimable under HRD Corp.