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EU Medical Device Regulations: A Q&A Guide, Exams of Nursing

University of WorcesterNursing

A series of questions and answers covering key aspects of european union medical device regulations. it explores the roles of regulatory bodies like the ema, the history of key directives (aimdd, mdd, ivdd), and essential principles for medical device advertising and promotion within the eu framework. The q&a format facilitates understanding of complex regulatory topics.

Typology: Exams

2024/2025

Available from 05/06/2025

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RAC Devices Exam Prep 2025 Questions and Answers
1. Who is the European Medicines Agency (EMA): Ans- 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.
2. Relevance of EMA in EU: Ans- 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 infor- ma tion on medicines
3. Mission of EMA: Ans- -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
4. New Approach (EU): Ans- 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
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Download EU Medical Device Regulations: A Q&A Guide and more Exams Nursing in PDF only on Docsity!

RAC Devices Exam Prep 2025 Questions and Answers

  1. Who is the European Medicines Agency (EMA): Ans- 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.
  2. Relevance of EMA in EU: Ans- 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 infor- ma tion on medicines
  3. Mission of EMA: Ans- -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
  4. New Approach (EU): Ans- 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.

  1. 1990s, New Approach (impact on MDs): Ans- EU regulations relating to medical devices' safety and performance were harmonised in the (date) _,
  1. advertising of a medicine shall encourage the rational use of the product by an objective pre- sentation and shall not be misleading
  2. prescription medicines may only be advertised to HCPs with the qualifications to prescribe or supply them
  3. OTC medicines may be advertised to the gen- eral public, subject to certain rules.
  4. 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
  5. differences between EU Member State national rules on medicinal product promotion versus the EU Directive: Some Member States

from 2000. Gives a detailed description of New Approach and Global Approach directives

  1. Although not formal law, the has influenced national laws on clinical research throughout the world deeply, including Europe, and continues to do so.: Helsinki Declaration
  2. SmPC: A document describing the properties and the officially approved con- ditions of use of a medicine. Summaries of product characteristics form the basis of information for healthcare professionals on how to use the medicine safely and effectively. 18. Impact of UK's exit from EU (on med device regs) (PLACEHOLDER):
  3. 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 recommenda- tions.

20. The Treaty brought public health into the EU's competence areas in (date).: Maastricht, 1993

  1. Harmonization (of standards) comes down to approval of a standard to be suitable to provide : Presumption of conformity
  2. 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
  3. 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
  4. 5 main tenets that MFRs must follow according to all Directives (AIMD, MDD and IVDD): 1. tech document with evidence of Essentail Requirement compliance
  5. a PMSS (post market surveillance system)
  6. a QMS
  7. Issue a Declaration of Conformity & appoint an AR (if no location in Europe)
  8. (a)register persons responsible for placing devices on the market;and (b)

Annex 2, 5 or 6 EXPAND

  1. 4 types of information an IVD may provide (per IVDD definition): 1. a phys- iological or pathological state
  2. congenital abnormality
  3. the safety or compatibility with potential recipients
  4. monitoring therapeutic measures
  5. Specimen receptacles used for are considered IVDs under IVDD: in- tended for the primary containment and preservation of human specimens for the purpose of in vitro diagnostic examination (excluding general lab use)
  6. If a member state does not comply with the Directive conditions, the can demand that the Member State amend their legislation and can start proceedings at the of .: European Commission; European Court of Justice 29. 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

  1. 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
  2. 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.
  3. The private labeler OR the manufacturer is ultimately responsible for com- pliance 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)
  4. Notified Bodies are called as such, because a notifies the that the entity has been designated to conduct certain types of audits: Com- petent Authority; European Commission
  1. Companion Diagnostics definition (per IVDR): an in vitro diagnostic device that provides information essential for the safe and effective use of a corresponding therapeutic product. Used before and/or during treatment
  2. The IVDR introduces a risk-based classification system with levels from to. Which Class will devices NOT covered by any of the rules in Annex VIII (8) fall into?: A to D. Devices not covered by Annex 8 will fall into Class B