Fifth Designation Of An MDR Notified Body In Italy As EU Total Reaches 23
Italy now has five notified bodies designated under the MDR, its number close to matching the German total.
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It is election month in Germany, and the medtech industry has been busy drawing up what it wants from the inevitable post-poll coalition agreement. But all-eclipsing still are the problems that the EU MDR is causing.
The regulation of medicines and medical devices have long worked along parallel, but very different, lines. Now there is increasing pressure for them to also be jointly improved to support innovation.
Unconstrained by having to compromise with other countries’ regulatory approaches, the UK is now seeking views on its proposal for a pioneering and “bold new regulatory regime” for medtech products.