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RAC Devices Exam Prep 2025 (EU) | Questions
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Who is the European Medicines Agency (EMA) - ✔✔an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. The primary reason for establishing EMA was to harmonise the work being done by the individual regulatory bodies in Europe. Relevance of EMA in EU - ✔✔founded in 1995, working across the EU to protect human and animal health by assessing medicines to rigorous scientific standards and by providing partners and stakeholders with independent, science-based informa tion on medicines Mission of EMA - ✔✔-Facilitate dev and access to medicines
- Evaluate applications for marketing authorisation
- Monitor safety of meds
- Provide info on human and vet meds to professionals and patients New Approach (EU) - ✔✔The basic concept is including Essential Requirements for safety and performance in the core legal text and publishing the technical specifications in harmonised standards. Other def: A innovative regulatory technique tha includes mandatory Essential requirements, conformity assessment procedures and CE marking. 1990s, New Approach (impact on MDs) - ✔✔EU regulations relating to medical devices' safety and performance were harmonised in the (date) _, following the legislative principles. AIMDD (# and date) - ✔✔Council Directive 90/385/ EEC, 20 June 1990 MDD (# and date) - ✔✔Council Directive 93/42/EEC, 14 June 1993
- advertising of a medicine must comply with the specifics in the summary of product char- acteristics (SmPC)
- advertising of a medicine shall encourage the rational use of the product by an objective pre- sentation and shall not be misleading
- prescription medicines may only be advertised to HCPs with the qualifications to prescribe or supply them
- OTC medicines may be advertised to the gen- eral public, subject to certain rules. EU's current position on medical device advertising - ✔✔there are no EU-level rules that provide an overarching regulatory framework for the advertising and promotion of medical devices.
prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance differences between EU Member State national rules on medicinal product promotion versus the EU Directive - ✔✔Some Member States have implemented processes for preapproval of promotional material in their local mar- ket surveillance regulations. the impact and aims of international and European codes of conduct and their implementation into national codes of conduct via trade associations (PLACEHOLDER) - ✔✔ Blue Guide - ✔✔The guide to the implementation of directives based on the New Approach and the Global Approach
The primary legislation in the EU is the while the main secondary legislations are the and. - ✔✔EU Treaty (constitution) and (secondary) is the Directives and Regulations. Other forms of secondary legislation include decisions, opinions and recommendations. The Treaty brought public health into the EU's competence areas in (date). - ✔✔Maastricht, 1993 Harmonization (of standards) comes down to approval of a standard to be suitable to provide - ✔✔Presumption of conformity Each Member state has established one or more dedicated regulatory bodies for and in their territory; these are called competent authorities - ✔✔market oversight and enforcement
The Directives and CE have been transposed into national law in (#) Member States, (#) members of the EEA, (#) EU candidate countries and (a country). - ✔✔27 Member States (was 28 before UK) 3 members of the EEA (Iceland, Lichtenstein and Norway) 5 EU candidates (Albania, Macedonia, Montenegro, Serbia and Turkey) PLUS Switzerland 5 main tenets that MFRs must follow according to all Directives (AIMD, MDD and IVDD) - ✔✔1. tech document with evidence of Essentail Requirement compliance
- a PMSS (post market surveillance system)
- a QMS
- Issue a Declaration of Conformity & appoint an AR (if no location in Europe)
- (a)register persons responsible for placing devices on the market;and (b) provide the CA of the Member State in which the place of biz is registrered with the address of the the business and device description
A CE mark is NOT a quality mark, nor is it a mark for consumers. It is intended for and is a visible sign to them that your product is... - ✔✔intended for Member State authorities; product is in compliance with the New Approach Directives Any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the MFR with regard to the latter's obligations under the Directives. - ✔✔Authorized Rep A body in the Member state responsible for ENFORCEMENT of directives and SURVEILLANCE of products already on the market. - ✔✔Competent Authority In most cases, not involved in approval of new products, but maybe in consultations relating to combo products. Reports to the Minister of Health in its Member State.
The private labeler OR the manufacturer is ultimately responsible for compliance with requirements of the medical directives. (PICK ONE) - ✔✔private labeler the original manufacturer would be referred to as the OEM or original equipment supplier (OES) Notified Bodies are called as such, because a notifies the that the entity has been designated to conduct certain types of audits - ✔✔Competent Authority; European Commission The new regulations entered into force in on the 26th of May in what year? - ✔✔ 2017
