EU RAC Exam Q&A Latest Update 2025

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EU RAC | Q&A Latest Update 2025/2026 | 100% PASS protocol is approved to ensure what? - Answer -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... - Answer -to collect required clinical data Instructions for Use language is defined by the Member State. Having a local distributor is not a mandatory requirement. - Answer -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. Answer -Directive 93/42/EC Directive states that any new therapeutic class of active substances must follow the centralized procedure. - Answer -Director 2004/27/EC The Notified Body is responsible for assessing parts of hte Conformity Assessment Procedures applied by manufacturers under commercial contracts - Answer -MEDDEV 2.4/1 If a manfuacturer is unsure how its devices should be classified, it should: - Answer -consult a notified body Notified Body - Answer -in the European Union, is an organisation that has been accredited by a Member State to assess whether a product