The European Federation of Pharmaceutical Industries and Associations (EFPIA) has released a report highlighting the need for harmonized regulatory requirements for digital health devices and apps. As it stands, only a few countries in the EU have standards for value assessment, reimbursement, and funding pathways. The EFPIA argues that this lack of harmonization constitutes a barrier to access for patients.
According to Nick Paul Taylor, “The trade group thinks ‘harmonization of regulatory requirements across the Member States would facilitate development and commercialization for developers, leading to faster access for patients and [healthcare professionals].’ EFPIA sees a role for the Medical Device Coordination Group in clarifying the interpretation of MDR. Clarification and harmonization could increase investment in startups and help companies ‘bridge the ‘valley of death’ between incubation and commercialisation,’ EFPIA said.”
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(Source: Regulatory Focus, June 8th, 2023)