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RAC Devices Exam Prep 2023 (EU) - Fundamentals of Medical Devices Regulations 3rd Edition
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RAC Devices Exam Prep 2023 (EU) - Fundamentals of Medical Devices Regulations 3rd Edition
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RAC Devices Exam Prep 2023 (EU) - Fundamentals of Medical Devices Regulations 3rd EditionWho 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
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
acknowledged statement of physicians' ethical responsibilities.
medicinal product advertising and promotion (#) ✔ Ans - EU Directive 2001/83/EC
Six (6) basic principles in EU Directive 2001/83/EC ✔ Ans - 1. medicines without a market authorisation shall not be advertised
2. no off-label indications advertising
3. advertising of a medicine must comply with
the specifics in the summary of product char-
acteristics (SmPC)
4. advertising of a medicine shall encourage the
rational use of the product by an objective pre-
sentation and shall not be misleading
5. prescription medicines may only be advertised
to HCPs with the qualifications to prescribe or
supply them
6. OTC medicines may be advertised to the gen-
eral public, subject to certain rules.
EU's current position on medical device advertising ✔ Ans - 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
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