European Union In-Vitro Diagnostic Device Regulation (IVDR)

NSF International, Pharmaceutical Services
Course summary
2 hours
399 USD
Online courses
Next available date: Enquire for more information - Online courses

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.

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Outcome / Qualification etc.


By completing/passing this course, you will attain the certificate Medical Device Certificate


Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.

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About provider

NSF International provides a comprehensive range of independent, third-party pharmaceutical and biotech support services covering consulting, training, auditing and regulatory guidance for the pharmaceutical industry. These services are delivered by some of the most knowledgeable experts in their fields. Our unique...

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NSF International, Pharmaceutical Services

The Georgian House, 22/24 West End
YO62 6AF York

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