Skip to main content

The European BioMedical Alliance (36 leading European medical societies that together include more than 400,000 researchers and health professionals) along with the European Federation of Clinical Chemistry & Laboratory Medicine (EFLM) have published a Statement: “Urgent action needed to prevent widespread shortage of diagnostic tests”.

This document points to the persisting problems with the implementation of EU IVDR. It calls out for the need for a short term action to increase efficiency in the IVDR, to support manufacturers in transitioning and providing a pathway for orphan devices. The Statement also supports reform of the regulatory system including a single accountable structure, providing for greater difference between class B and C devices and reducing administrative burden. The Statement further calls for early adoption of EUDAMED, a form of conditional grandfathering for legacy devices, considerations for in-house assays (lab developed tests) and a legislative requirement to report device discontinuations at least 6 months in advance to end users and regulators.


This information is kindly provided by MedTech Europe.