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.
Canada
The new article clarifies the recall procedure in the context of the roles and responsibilities of the parties involved.
Bahrain
The article describes in detail the transitional arrangements associated with the recent regulatory changes in the European Union.
EU
The article describes in detail the regulatory approach to be applied in the context of the importation and distribution of medical devices in the EU, focusing on the obligations of the parties involved.
EU
The article highlights the key points associated with interpreting specific regulatory provisions of the current European legislation in medical devices.
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