Примери за използване на Joint clinical assessment на Английски и техните преводи на Български
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The conclusions of the joint clinical assessment report shall include.
Such scanning should facilitate the prioritisation of technologies that are to be selected for joint clinical assessment.
(b) not duplicate the joint clinical assessment at Member State level.
The designated sub-group shall appoint, from among its members, an assessor anda co-assessor to conduct the joint clinical assessment.
The conclusions of the joint clinical assessment report shall be limited to the following.
The designated sub-group shall appoint, from among its members, an assessor anda co-assessor to conduct the joint clinical assessment.
A selection of medical devices for joint clinical assessment should be made based on specific criteria.
Such scanning should facilitate the prioritisation of technologies that are to be selected by the Coordination Group for joint clinical assessment.
The fundamental aim of the proposal is to introduce a joint clinical assessment of health technologies at EU level.
(b) apply joint clinical assessment reports, in their health technology assessments at Member State level.
The designated sub-group shall appoint, from among its members, an assessor anda co-assessor from different Member State to conduct the joint clinical assessment.
(b) apply joint clinical assessment reports, in their health technologynot duplicate the joint clinical assessments at Member State level.
For the health technologies included on the List of Assessed Health Technologies or in respect of which a joint clinical assessment has been initiated, Member States shall.
When updating the joint clinical assessment report, the Member State shall apply the methods and standards as laid down by the Coordination Group.
Member States shall notify the Commission and the Coordination Group of their intention to complement the joint clinical assessment together with a justification for doing so.
The assessor shall provide the draft joint clinical assessment report and the summary report to the health technology developer for comments.
The Coordination Group shall select the medical devices referred to in paragraph 1 points(b),(ba) and(c)for joint clinical assessment based on the following criteria.
The initial joint clinical assessment report specified the need for an update once additional evidence for further assessment is available.
The assessor, with the assistance of the co-assessor, shall modify the joint clinical assessment report and summary report accordingly and submit them to the Coordination Group.
The technology developer shall provide the data andresults of conducted comparative trials in the documentation dossier submitted for the joint clinical assessment.
The designated sub-group shall review the joint clinical assessment report and summary report taking into account the comments provided by the health technology developer.
Delegates and experts participating in joint scientific consultations for a given health technology shall not participate in the joint clinical assessment of this technology.
The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by a simple majoritytwo-thirds of Member States.
The designated sub-group shall request relevant health technology developers to submit documentation containing the information, data andevidence necessary for the joint clinical assessment.
The Coordination Group shall select the medical devices referred to in paragraph 1 points(b)and(c) for joint clinical assessment based onif the device in question fulfils all of the following criteria.
(b) the initial joint clinical assessment report specified the need for an update once additional evidence for further assessment is available within the deadline set in that report;
Delegates participating in the elaboration of joint scientific consultations for a health technology may not participate in the joint clinical assessment of this particular technology.
Should additional relevant evidence become available prior to the renewal of the marketing authorisation,the Coordination Group shall also consider carrying out an update of the joint clinical assessment.
Members of the Coordination Group participating in the elaboration of joint scientific consultations for a health technology shall not also participate in the joint clinical assessment of the same health technology.
Should additional important evidence become available significantly prior to the renewal of the marketing authorisation,the Coordination Group may also consider carrying out an update on joint clinical assessment.