European Regulatory changes affecting IVDs
(EU 2017/746)
Course Cost
Early Bird Price £495 + VAT
Upcoming Courses
- Requirements for Persons responsible for Regulatory Compliance
- Claims of equivalence with another marketed IVD
- Unique Device Identifier and own brand labelling and EAR
- Risk Classifi cation of IVDs
- Clinical Evidence Requirements for different risk classes
- Electronically programmed systems
- EUDAMED and statutory reporting (PSUR)
- Identification within the supply chain

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