Course description
European Union In-Vitro Diagnostic Device Regulation (IVDR)
In 2017, the In Vitro Diagnostic Device Regulation (EU IVDR) 2017/746 was published, introducing major changes to the previous In Vitro Diagnostic Device Directive (IVDD 98/73/EC). Significant changes include changes associated with notified bodies, new risk classes based on a set of classification rules to determine conformity assessment requirements, reinforcement of rules on clinical evidence, strengthening of post market requirements and additional requirements for certain IVDs. To comply with the new EU IVDR, in vitro diagnostic medical device manufacturers must plan carefully to ensure the new requirements are fully understood and they identify appropriate resources for full implementation. This on-line course provides comprehensive instruction on the EU IVDR and walks learners through every aspect of the regulation, identifying key topics and changes.
Upcoming start dates
Outcome / Qualification etc.
Certificate
By completing/passing this course, you will attain the certificate Medical Device Certificate
Training Course Content
By the end of this course you should be able to:
- Recognize the major changes for the EU in the new IVD Regulation
- Identify key roles associated with the EU IVDR
- Discuss the requirements of the IVD Regulation for key actors
- Explain how to comply with pre and post market requirements for conformity assessment
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
Customer Outreach Award
We believe that it should be easy for you to find and compare training courses.
Our Customer Outreach Award is presented to trusted providers who are excellent at responding to enquiries, making your search quicker, more efficient and easier, too.
Expenses
Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.