Medical Devices- Marketing

Medical Devices- Marketing

Poster

Slavyan Boyanov, Emil Hristov, Zlatka Dimitrova, Kalina Andreevska
Faculty of Chemistry and Pharmacy, Sofia University “Saint Kliment Ohridski”, Sofia, Bulgaria

Introduction: With the new Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical devices and Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices, the EU legislation is being aligned accordingly with technological advancements, the advancements in medical sciences and legislation creativity. Methods: Document analysis and content analysis. Results: The new regulations create a stable, transparent, sustainable and internationally recognized regulatory framework, thus achieving a higher level of clinical safety, and creating conditions for equal access to the market from producers of medical devices. Compared to the current directives, RMD sets a larger emphasis on a clinical data- supported life- cycle approach to safety. The RMD introduces stricter requirements for the designation of notified bodies, strengthening control and monitoring by the national competent authorities and the Commission. A new system for the unique identification of products will significantly increase the traceability and efficiency of post marketing activities. The RMD will also provide greater transparency, for example, more detailed information bout the products and studies will be made public. The new European database for medical devices -EUDAMED- will play an important role for providing data and increasing both its quantity and quality. Conclusion: Directives and the RMD are largely the same basic regulatory requirements.
Keywords: Medical devices, regulatory, marketing