The article describes in detail the regulatory procedures to be performed for an application for designation as a conformity assessment body under the new...
The article provides an overview of the European regulatory requirements in the sphere of conformity assessment bodies and notified bodies set forth by the...
The article provides an overview of the clarifications provided concerning solutions available during the temporary unavailability of the global European database.
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The new article describes in detail the aspects related to the documents the authority expects the applicant to submit concerning the clinical trials.
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The new article describes in detail the general rules related to the importation permits, as well as certain specific aspects, such as violations, product...
The new article describes specific aspects related to the registries containing information about clinical trials, and also to the Investigator’s Brochure – a particular...
The new article explains the three steps testing approaches and highlights the key points associated thereto. The document also addresses the aspects related to...
The new article provides additional clarifications regarding certain specific aspects related to post-market surveillance, including the activities to be undertaken by the parties involved...