Implementation and Advanced Requirements of EU MDR 2017/745

WHAT YOU'LL GAIN BY ENROLLING FOR THIS COURSE?

• Gain a globally accepted course completion certificate
• Gain functional knowledge of EU MDR 2017/745 and ISO 13485:2016
  
• Learn how to transition from MDD to MDR
  
• Get an understanding about the CE certification process and timelines

ABOUT THE COURSE

For medical device manufacturers, implementation of European Medical Device Regulations is one of the primary requirements while placing their products in the European market. Along with this, medical device manufacturers need to ensure compliance towards the EU MDR for getting the Conformité Européene (CE) markings on the products. Through our training program, we help you understand the process of CE markings. The European Council Directives 90/385/EEC and 93/42/EEC have been revised to Regulation (EU) 2017/745. The two-day training helps you gain knowledge about and transitioning from the MDD to MDR. The Regulation (EU) 2017/745 covers medical devices and active implantable medical devices. This regulatory framework defines the expectations of the European Commission and medical device manufacturers, notified bodies, and member state competent authorities.

COURSE CONTENT/OUTLINE

• Introduction to the European Union Medical Device Regulation
• Implementation timelines for manufacturers
• Regulatory expectations against various annexes
• General Overview of training:
  • Question and answer session
  • General safety and performance requirements
  • Technical documentation
  • What is meant by the EU Declaration of Conformity?
  • What information will be submitted upon device registration, including the UDI system?
  • Requirements to be met by Notified Bodies
  • Classification rules for medical devices
  • Conformity assessment based on quality management system and assessment of the technical documentation
  • Conformity assessment based on type examination
  • Conformity assessment based on product conformity verification XII Certificates issued by a notified body
  • Procedure for custom-made devices
  • Learnings of clinical evaluation and post-market clinical follow-up
  • Carrying out clinical investigations
  • List of groups of products without an intended medical purpose

• Technical documentation on post-market surveillance
• Examination – MCQ-based

TRAINING DURATION

2 days

WHO SHOULD ATTEND?

Research and Administration

• Product developers
• Regulatory managers
• Quality assurance
• R&D professionals

Engineering

• Engineers

Management

• Operational managers

• Manufacturing managers

• Other service providers associated with the medical devices industry

EXAMINATION AND CERTIFICATION

The Implementation and Advanced Requirements under EU MDR 2017/745 can be obtained by enrolling and attending our instructor-led training program. Post-completion of the EU MDR training course, participants are required to attend an examination containing multiple-choice questions to obtain the certificate. Participants scoring above the passing criteria would be awarded the successful completion certificate by TÜV SÜD South Asia.

Examination Pattern

Exam Type: Multiple choice
Exam Questions: 50
Exam Time: 60 minutes
Required number of points: 30 points
Maximum number of points: 50
Aids: Open Book
Passing Criteria: 60%

For more details, get in touch with us at [email protected]