Significant changes are on the horizon for clinical trials in Germany. At the end of January 2024, the German Federal Health Ministry has presented the draft for a “Medical Research Act” (Medizinforschungsgesetz or MFG). The draft bill proposes legislative amendments in several areas that span from
Continue Reading Germany will revise laws for clinical trials with pharmaceuticals, medical devices and companion diagnostics – Overview of the “Medical Research Act”companion diagnostics
IVD Regulation and Companion Diagnostics – EU Council Dramatically Changes Definition
By Inside EU Life Sciences on
Posted in Food & Drug Regulatory, Medical Devices
This post was originally published on our sister blog Inside Medical Devices.
On June 19th, 2015, the Council of EU Ministers reached a partial General Approach on the review of the medical devices and in vitro medical devices (IVD) rules in the EU (an overview of the texts is accessible here). The General Approach does not yet include the recitals to the new medical devices and IVD regulations.
The Council’s text on the new IVD Regulation significantly amends the Commission’s proposed definition of ‘companion diagnostics’, an evolution relevant to sponsors of both medicinal products and diagnostic devices. The Council’s definition of companion diagnostics is almost identical to the definition used by the FDA, but significantly different from the European Commission’s proposal and the European Parliament’s suggested amendments. An overview is set out below.
Continue Reading IVD Regulation and Companion Diagnostics – EU Council Dramatically Changes Definition