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EU medical device and diagnostic regulatory overhaul: a guide for novices

Monday, 18 September 2017  
Posted by: Website Administrator
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On May 26th 2017, a new set of European Medical Device Regulations (“MDR”) and In Vitro Diagnostic Regulations (“IVDR”) entered into force. They represent a major overhaul and tightening of the previous directives and affect all companies marketing or developing devices and/or diagnostics under their name or trademark in the EU (termed ‘manufacturers’ in the regulations).


The changes introduce a standardised regulatory framework for the EU that aims to be robust, transparent, and to overcome differences in interpretation and weaknesses brought to light in recent safety scandals.


Download the full PDF Report.

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