European Regulatory changes affecting IVDs

(EU 2017/746)

Course Cost

Early Bird Price £495 + VAT
Available as In house course

Upcoming Courses

Wednesday 27 March 2019
Unlimited
£495.00

  • 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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01236 734447

Early bird discounts are obtained by reserving a place and paying the discounted fee at the time of booking or invoice date. Two for less discounts are available for two or more people from the same organisation attending the same course, making the reservation at the same time and paying the discounted fee by the invoice date. For all discounts no cancellation refunds are available but transfer may be possible with at least 15 days notice.

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