European Parliament Calls For Risk-Related Extensions Under MDR And IVDR

With the EU’s Employment, Social Policy and Consumer Affairs Council due to discuss solutions to the MDR crisis on 9 December, the European Parliament is calling for risk-related deferrals.  

stopping the Dominio effect
European Parliament Calls On Commission To Make Final Postponements To Medtech Regulations

The European Parliament’s committee on the environment, public health and food safety (ENVI) has told the European Commission to get on with adopting proposals to address problems with the implementation of the Medical Device Regulation (MDR) speedily - "given that a deferral is inevitable.”

Any delays proposed by the commission should be “linked to the risk class of devices in order not to endanger the public safety that these regulations are meant to ensure,”...

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