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Browsing by Subject "yhdistelmätuote"

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  • Aalto, Aura (2019)
    Medicinal products, medical devices and combination products, that include both the medicinal product and medical device part, need to fulfill the regulatory requirements for their efficacy, safety and quality before they can be placed on the market. Documentation requirements, application processes and authoritative processing differ between medicinal product and medical device registration. In European Union, combination products are registered either as medicinal products or medical devices according to their principal mode of action. Registration requirements for medical devices are currently changing since the new medical device regulation 2017/745 (MDR) in the EU came into force in May 2017. Transition period in MDR implementation will last until May 2020. This study is continuation to an earlier study (Nuolimo 2016) where registration process differences between medicinal products and medical devices were investigated. In the earlier study it was concluded that registration process differences seem to favour the registration of the product as CE marked medical device in borderline cases where the product can be registered both as medicinal product and medical device. The aim of this theme interview study was to further clarify registration process differences and particularly underlying factors affecting the selection of the registration status. Furthermore, the study aimed to clarify how the registration process for combination products differs from other registration processes and how the new European medical device regulation 2017/745 influences registration work in practice. In the theme interview study, regulatory affairs professionals with experience from the different product groups were interviewed. In total, eight interviewees participated in the study. Regulatory professionals’ job descriptions varied so much that it was difficult to compare registration processes. Registration process for medical devices was discovered to be lighter than the equivalent for medicinal products. Registration status is chosen product-specifically. Load in registration process for combination products depends on whether the product is registered as a medicinal product or as a medical device. Regarding combination products, borderline cases where it needs to be determined whether the product is registered as a medicinal product or a medical device, can be challenging. Implementation of the new medical device regulation (MDR) was still incomplete when the study was conducted. However, the regulation had already increased workload in medical device and combination product registration and created new business opportunities for contract research organisations.