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This publication provides an overview of the regulations and legislations with regard to commercialisation of medical devices. The product category of medical devices includes in vitro diagnostics (IVDs), active implantable medical devices (AIMDs) as well as medical software. In Europe, market approval for medical devices is achieved via a decentralised procedure of CE marking, whereby quality and safety is addressed, and registration of the product. This procedure is in compliance with European regulations and with national legislation of the countries in which market entry is planned. In the US, market approval is granted by the FDA upon assessment of quality, safety and effectiveness. Though complex, the decentralised European system seems to speed up the access to medical devices at least three years as compared to the central system in the US or systems elsewhere in the world.
The information provided here informs start-ups, spin-offs and biotech companies about the differences in regulative procedures for specific classes of medical devices and between the authorities and regulations in Europe and the US. By summarising the build-up of a technical file, the significance of a quality management system (QMS), the selection of Annexes, the advantages of adherence to ISO standards, the use of MEDDEV guidelines and the procedures for standalone software and IVDs specifically, we aim to offer a guide through dense regulative and legislative landscape. These insights can be used to design the optimal market introduction strategy for your medical device.