EU
The new article elaborates further on the matters related to on-site assessment activities to be undertaken in the context of the designation process.
Great Britain
The new article outlines the list of questions raised by the regulating authority in the context of the initiated consultation and also provides definitions of the most important terms and concepts used.
Great Britain
The new article describes in detail the new regulatory policy for in vitro diagnostic medical devices as suggested by the UK authority.
Great Britain
The new article provides an overview of the regulatory approach to medical devices allowed for marketing and use in the United Kingdom.
EU
The new article clarifies the aspects related to the pre-clinical evaluation the device should undergo before it will be allowed for use in patients.
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