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Development of (biophotonic) devices within a university hospital and the clinical implementation has been workable up till recently. An innovation starts with an idea or solution for a clinical problem during interactions between physicians and biomedical engineers. After a well documented design and development of a prototype by the R&D workshop within an university hospital, in vitro/ex-vivo feasibility tests are performed. The results are used to make a risk analysis/safety report in preparation for clinical feasibility study. A comprehensive dossier is submitted to the ethical committee for approval. Since most biophotonic devices are non invasive and/or non-contact during clinical application, it is less complicated to obtain ethical approval. Officially, devices without CE mark are not allowed in the hospital except with ethical approval for a clinical study. It will be harder to obtain all the approvals for a multi-center trial.
Recently, European guidelines for CE marking of medical devices (MDD) have been replaced by the Medical Devices Regulations (MDR) which has a major impact on existing and new medical devices.
Prototypes are only allowed for clinical studies if they are produced by an ISO 13485 certified R&D department. The clinical effectiveness has to be proven and CE approved medical devices need recertification within 3 years. The capacity of ethics committees and clinical studies in hospitals is limited and expensive. Furthermore, capacity of notified bodies is potentially decreasing by 50% due to the Brexit. In contrast to the less strict directions of the FDA, the introduction of the MDR in Europe makes it very challenging to obtain CE marking and the introduction of new medical devices could dramatically slow down in the next years.
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