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The progressive rollout of the In-vitro Diagnostic Medical Devices Regulation (IVDR) is now officially adopted by the European Parliament and the Council. LDTs in particular have an implementation period of up to six years with different steps by May 2022, May 2024 and May 2028.
What is often misunderstood is that key parts of the IVDR are not being postponed!
The “General Safety and Performance Requirements” (GSPRs) in Annex I represent the "heart" of the IVDR and stay in force according to the original schedule (active from May 2022).
Failure to comply by May 2022 can result in serious legal consequences for clinical laboratories.
Platomics partnered with the Johner Institute to host a webinar. We also presented a digital assistant to evaluate which GSPRs apply, where gaps exist and how to close them.
GOALS OF THE WEBINAR
raise awareness about the GSPRs
inform which actions are required from the labs
outline legal implications
Introduction of a digital assistant for assessment and documentation of GSPRs
DR. SEBASTIAN GRÖMMINGER
Johner Institute GmbH
DDR. KARINA HELLBERT
Legal Expert on Medical Devices
DI ANDREAS OBERLEITNER
Head of Regulatory