In Vitro Diagnostic Regulation (IVDR)
With this interactive training program, you will:
- Receive a recognised certificate from TÜV SÜD, demonstrating your understanding of the European Regulation 2017/746 related to in vitro diagnostic (IVD) devices.
- Gain essential knowledge of the major changes introduced by the IVDR, including the new risk-rule classification system and its impact on IVD manufacturers.
- Develop a thorough understanding of the regulatory framework and requirements applicable to in vitro diagnostic devices under the new Regulation.
- Learn about the increased responsibilities and product data expectations for manufacturers, importers, and distributors under the IVDR.
- Acquire practical skills to conduct gap analyses and implement necessary changes to ensure compliance with IVDR requirements.
- Network with professionals from the IVDR industry, sharing experiences and building relationships with peers facing similar regulatory requirements.
- Enhance your professional qualifications and broaden your career prospects in the field of in vitro diagnostics and regulatory affairs.
- Prepare yourself to support your organisation in achieving and maintaining compliance with the IVDR, ensuring the safety and performance of in vitro diagnostic devices in the European market
At the end of the course, you will:
- Get an overview of the European Regulation 2017/746 related to in vitro Diagnostic Devices
In this program, you will learn the following:
- IVD Regulation - Introduction
- Obligations of economic operators
- Classification of IVD medical devices
- Conformity assessment procedures
- Technical documentation
- Performance requirements
- Traceability requirements
- Post-Market Surveillance, vigilance and market surveillance requirements
- Transition Timeline
The course is specially designed for:
- Newcomers in the medical device industry
- Expert and executive personnel to update their knowledge
- Personnel in charge of regulatory affairs
- Personnel in quality management
- Consultants in the medical device industry
The career prospects for the In Vitro Diagnostic Regulation (IVDR) Training Programme are highly promising. As the medical device industry adapts to new regulatory standards, there is a growing demand for professionals knowledgeable in IVDR requirements.
Career prospects include:
- Regulatory Affairs Specialist
- Quality Assurance Manager
- IVD Product Manager
- Compliance Officer
- Clinical Affairs Specialist
- Medical Device Consultant
The course content and structure are developed by the domain experts from TÜV SÜD. With immense experience and knowledge of the relevant standards, our team of product specialists and technical experts at TÜV SÜD have developed the course content based on the current business landscape and market requirements.
Upon completing the course, you will receive a certificate from TÜV SÜD.
1. Can I also attend e-learning courses on top of attending the In Vitro Diagnostic Regulation (IVDR) course?
Yes, you can register for any e-learning course at TÜV SÜD.
2. How do I enroll for the In Vitro Diagnostic Regulation (IVDR) course?
To enroll, please click on "Buy now" and check out your cart.
3. What is the In Vitro Diagnostic Regulation (IVDR) course methodology?
Participants will learn through lectures, case studies, group exercises and discussions.
4. Can I get a refund if I cancel my enrolment?
- If you communicate the cancellation to us by email within 14 days before the confirmed training date, we will not provide a refund for the training.
- If you communicate the cancellation to us by email more than 14 days before the confirmed training date, we will provide a 50 % refund for the training.
5. Are there any tests in the middle of the course?
There are no in-between assessments, but case studies will be included in the In Vitro Diagnostic Regulation course.