IVDR Guidance Published Until Eudamed is Fully Functional

IVDR Guidance Published Until Eudamed is Fully Functional – published on cemarking.net – July 18, 2022

Why this IVDR Guidance?

In the absence of a Eudamed database, the European Commission released guidelines on Wednesday for European Union member states and other parties on the implementation of certain In Vitro Diagnostic Medical Devices Regulation (IVDR) rules.

According to the EU, the guideline “intends to describe harmonized administrative practices and alternative technical solutions for information exchange until Eudamed becomes fully functioning.” The guidelines will enable member states and others to satisfy their commitments now that the IVDR’s phased implementation has begun while minimizing extra costs.

The guideline is intended for situations in which “the exchange of information would be difficult, if not impossible, to achieve based on the equivalent requirements of the in vitro diagnostic medical equipment directive,” according to the commission.

IVDR Guidance Published Until Eudamed is Fully Functional | Photo by Tetiana SHYSHKINA on Unsplash

IVDR Guidance With an Amendment to the Timeframe

The European Commission has amended its timeframe for a fully operational Eudamed, with the goal of having the medical device database fully operational by the second quarter of 2024.

Eudamed is a database that will record every medical device permitted for use in the 27-member European Union, allowing national medical authorities and device manufacturers to be aware of authorized device usage, safety concerns, recalls, and new laws.