Taking Steps Towards Improving Innovation Opportunities In The EU Regulatory Environment
The German notified body, TÜV SÜD, is looking to help create a more favorable regulatory environment for medtech innovation within the EU as the debate continues over damaging MDR/IVDR implementation practices.
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Manufacturers delaying their MDR transition could disrupt notified body planning and make a mockery of the whole sector’s efforts to achieve the extend timeline now in place for legacy products.
The medtech sector will be relieved to see this latest document relating to the implementation of the EU’s Medical Device and IVD Regulation. Its concrete proposals address multiple concerns.
Work related to the European Commission’s promise to assess the impact of the Medical Device Regulation, including its impact on innovation, is starting to take shape.