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RAC Devices Exam Prep 2021 (EU)
Questions and Answers Latest 2026
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.
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
informa tion on medicines
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
© 2025 All rights reserved
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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.
1990s, New Approach (impact on MDs) Ans: EU
regulations relating to medical devices' safety and
performance were harmonised in the ____(date) _,
following the _____ _____ legislative principles.
AIMDD (# and date) Ans: Council Directive 90/385/ EEC,
20 June 1990
MDD (# and date) Ans: Council Directive 93/42/EEC, 14
June 1993
IVDD (# and date) Ans: Directive 98/79/EC of the
European Parliament and of the Council, 27 October 1998
key historic developments influencing today's EU
healthcare regulations - ETHICS Ans: the Nuremberg
Code, was drafted in 1947.
The Helsinki Declaration of 1964 further developed
the Nuremburg Code's principles, and tied them to
the Declaration of Geneva (1948), an internationally
© 2025 All rights reserved
RAC Devices Exam Prep 2021 (EU)
Questions and Answers Latest 2026
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.
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
informa tion on medicines
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
© 2025 All rights reserved
, 2 | Page
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.
1990s, New Approach (impact on MDs) Ans: EU
regulations relating to medical devices' safety and
performance were harmonised in the ____(date) _,
following the _____ _____ legislative principles.
AIMDD (# and date) Ans: Council Directive 90/385/ EEC,
20 June 1990
MDD (# and date) Ans: Council Directive 93/42/EEC, 14
June 1993
IVDD (# and date) Ans: Directive 98/79/EC of the
European Parliament and of the Council, 27 October 1998
key historic developments influencing today's EU
healthcare regulations - ETHICS Ans: the Nuremberg
Code, was drafted in 1947.
The Helsinki Declaration of 1964 further developed
the Nuremburg Code's principles, and tied them to
the Declaration of Geneva (1948), an internationally
© 2025 All rights reserved
