RAC Devices Exam Questions and Answers Graded A+ 2023 update

1 / 11 RAC Devices Exam Questions and Answers Graded A+ 2023 update 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 2 / 11 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. 5. 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. 6. AIMDD (# and date): Council Directive 90/385/ EEC, 20 June 1990 7. MDD (# and date): Council Directive 93/42/EEC, 14 June 1993