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.
