Regulatory Focus™ > News Articles > European Commission to Revise IVD Regulatory Framework

European Commission to Revise IVD Regulatory Framework

Posted 21 September 2012 | By Louise Zornoza 

The European Commission (EC) plans to adopt a new proposal to revise the regulatory framework for in vitro diagnostic (IVD) medical devices in Europe during the week of 27 September, its commissioner has announced. 

The proposal is intended to facilitate the development of personalized medicine by enhancing the safety and performance requirements applicable to the IVDs that will serve as companion devices to new drugs.  According to European Commissioner for Health and Consumer Policy, Dalli, the proposal will provide the clarity and legal certainty necessary to pave the way for innovation in personalized medicine. Dalli made the announcement in a speech to the European Parliament on personalized medicine on 18 September.


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