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EU RAC Exam with correct Answers
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EU RAC Exam with correct Answers
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EU RAC Exam with correct Answersprotocol is approved to ensure what? - Answers -That it meets applicable quality and
study design requirements.
First course of action to market a new class III medical device technology in the shortest
time is... - Answers -to collect required clinical data
Instructions for Use language is defined by the Member State. Having a local distributor
is not a mandatory requirement. - Answers -Transposed Meidcal Devices Directive.
If the Essenntial Requirements are met by stating conformance to a standard and the
standard is revised, the changes must be evaluated to ensure conformance with the
standard can still be demonstrated. - Answers -Directive 93/42/EC
Directive states that any new therapeutic class of active substances must follow the
centralized procedure. - Answers -Director 2004/27/EC
The Notified Body is responsible for assessing parts of hte Conformity Assessment
Procedures applied by manufacturers under commercial contracts - Answers -MEDDEV
2.4/1
If a manfuacturer is unsure how its devices should be classified, it should: - Answers -
consult a notified body
Notified Body - Answers -in the European Union, is an organisation that has been
accredited by a Member State to assess whether a product meets certain preordained
standards. Assessment can include inspection and examination of a product, its design
and manufacture. For example, a Notified Body may designate that a medical device
conforms to the EU Medical Devices Directive, which defines the standards for medical
devices. With this Declaration of Conformity, the manufacturer can label the product
with the CE Mark, which is required for distribution and sale in the EU.
Significant changes to an Annex II list A IVD should be documented int he design
dossier and reported to the notified body - Answers -on a continuous basis
The applicant shall inform the Notified Body that issued the EC design examination
certificate of any signficant change made to the approve design - Answers -In Vitro
Devices Directive (98/79/EC) Annex III
Abridged Application - Answers -an application for marketing authorization that, based
upon demonstrating essential similarity or by detailed references to published scientific
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