Geographic Coverage: Europe
Learning Level(s): Intermediate: Content is appropriate for individuals who have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s).
SessionType: Featured session
This presentation proposes to analyze the implementation of national Regulations for non-EU countries and how it relates to the EU Medical Device Regulations. We will discuss some of the key points that companies should take into account when developing their strategy to market medical devices in non-EU Member states, the pros and cons, and the perspective non-EU countries should have when initiating the recognition of the MDR in their national laws as well as in the development of new requirements in order to guarantee the Conformance and Safety of Medical Devices.