27 Jul 1.24 Page 120 TD1 Legal and Regulatory Requirements. Are you expecting the solution and associated medical devices to be submitted and fully licensed in the countries before the Phase III? Have you factored in the legal and registration costs involved for each country and can you share these costs? Spain: do you have details of regional health ministry requirements? Greece, Turkey require specific registration which will take a considerable length of time (and cost) has this been factored into the Phase III timeframe as registration will not be possible until the end of phase II has been completed to allow full technical requirements to be documented.
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PCP is a pre-commercial procurement for the research and development of an integrated “non-commercial” solution; the certification of the components as Medical Devices (MD) is not required at this stage.
But if the solution involves the integration and use of software / App / Devices, already on the market, which correspond to the definition of Medical Device they must be certified.
Furthermore, certification as a medical device is necessary for commercial or large-scale use therefore, Bidders should consider the issue of certification as a topic of their feasibility study and business plan and therefore it is important to include it as requirements within the Call for Tenders Documents.