Status of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations

The adoption of these two important EC regulations is not making any progress.

At the last meeting of the EPSCO Council of the Italian Presidency on 1 December 2014, the Council acknowledged that further discussions on a set of outstanding issues were required for the Council to adopt a position. Since then, the situation seems not to have changed substantially.

While the current Latvian Presidency should see an adoption of a Council position on these dossiers, they do not seem to be going anywhere quickly. The key issue that is holding up a proper Council position is the Reprocessing (Articles 4 and 15). 

The German Government refuses to move from its own national position, which is precisely what was done last time this legislation was reopened. In this context, it does not seem likely that the trialogues will start any sooner than the second half of this year.


Date: 30/03/2015 | Tag: | News: 362 of 590
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