Important note: term ‘regulations’ can be used in
different contexts while an EU regulation is a legal act of the European Union that becomes immediately enforceable as law in all member states
simultaneously. EU regulations can be distinguished from EU directives which,
at least in principle, need to be transposed into national law.
The purpose of this module is to introduce you to health technology assessment (HTA). In these courses you ...
Health Technology Assessment (HTA)
The purpose of this module is to introduce you to health technology assessment (HTA). In these courses you will learn what a health technology is, what HTA stands for and actually is, and why it is becoming increasingly popular within European health systems.
You will learn best approaches to HTA, and how patients can become involved with HTA within their respective health systems.
Since there is no single approach to HTA, you will learn the different approaches and types of information that are used and what might be thought of as ’best’ approaches. Having an understanding of what health systems need, and how HTA is one key mechanism to address the needs of patients should help to promote and make patient participation in HTA more effective.
The courses in this module will give you an overview on the Medical Devices and their regulatory framework....
The courses in this module will give you an overview on the Medical Devices and their regulatory framework. You will learn about the history of the Medical Devices, different classifications, the role of Notified Bodies and Conformity Assessment, CE marking and re-certification. You will also acquire knowledge about the Medical Devices development and the lifecycle management under the MDR and IVDR and new technologies in the context of Medical Devices and in vitro diagnostics (IVDs). You will learn about the general principles for market access and market access for Medical Devices and the different aspects of Value-based innovation. These courses also provide key definitions about Health Technology Assessment (HTA) in Medical Devices and HTA principles in Medical Devices and in vitro diagnostics (IVDs).