Advancing the regulation of medical devices with regulatory science
This article was originally published in Clinica
Advances in medical technologies mean authorities are now coming across new products which cannot be adequately regulated by existing systems. Dr Gabriel Adusei, founder of the International Association of MedTech Consultants, discusses how applying the principles of regulatory science can enable regulators to meet these challenges
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In the EU, the European Commission is encouraging member states to increase the exchange of National Competent Authorities Reports (NCARs). Its staff working document on the impact assessment on the revision of the regulatory framework for medical devices - published in September 2012 - also encourages them to share knowledge and competencies. In this article, Gabriel Adusei* makes a series of recommendations that could improve market surveillance and vigilance not only in the EU, but globally
Gabriel Adusei suggests how shortcomings in the quality standard for medical devices might be fixed.
As medical technology advances, regulations become more stringent, and standards must adapt to reflect the regulatory advances. But one of the most critical to the medtech industry is failing to keep up with regulatory progress in the EU and is becoming outdated. In this article, independent medtech consultant Gabriel Adusei argues why the sticking plaster approach to the EU quality management system standard is not enough