Despite the clinical advantages offered by combination products in treating certain medical conditions, the regulatory review and approval of medical device combination products is generally more complex than that applicable to non-combination products. In the European Union (EU), for example, the evaluation by a Notified Body of medical devices incorporating medicinal substances must include an opinion of a competent authority designated by an EU Member State, a process that can take more than 210 days (210 days + clocks stops) to complete. In the U.S., the Food and Drug Administration (FDA) handles the pre-market approval of medical device combination products through its Office of Combination Products (OCP), which then determines the appropriate process based on a review of the device’s primary mode of action (PMA). However, this determination alone can take up to two months before the actual pre-market review commences.
Manufacturers of combination products are encouraged to develop a detailed regulatory strategy as early as possible in the development process for new combination products. An effective regulatory strategy can provide a detailed plan and schedule for the regulatory approval process that is consistent with the manufacturer’s plans for market introduction. Medical device combination product manufacturers should also seek advice from regulators, authorities and competent third-parties regarding the documentation required to support CE mark approval applications, including clinical evaluation reports, drug file (CTD-Format) and technical documentation. These steps serve to make the approval of combination products as efficient as possible, and can help reduce the risk of unexpected challenges and setbacks that can prolong or jeopardize product approval.
TÜV SÜD Product Service experts understand drug/device combination products and can conduct a pre-assessment of the clinical evaluation report for the product prior to submission. In addition, TÜV SÜD Product Service has a global staff of medical device experts, with over 400 international specialists located in major markets around the world. These specialists are supported by TÜV SÜD Product Service’s own Clinical Affairs department, and a scientific advisory board comprised of scientists and physicians from the leading universities and healthcare centers.
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