RAC Devices Prep Exam Updated 2024 (EU) Rated A+1990s, New Approach (impact on MDs) - EU regulations relating to medical devices' safetyand performance were harmonised in the ____(date) _, following the _____ _____ legislativeprinciples.AIMDD (# and date) - Council Directive 90/385/ EEC, 20 June 1990MDD (# and date) - Council Directive 93/42/EEC, 14 June 1993IVDD (# and date) - Directive 98/79/EC of the European Parliament and of the Council, 27October 1998key historic developments influencing today's EU healthcare regulations - ETHICS - theNuremberg Code, was drafted in 1947.The Helsinki Declaration of 1964 further developedthe Nuremburg Code's principles, and tied them tothe Declaration of Geneva (1948), an internationallyacknowledged statement of physicians' ethical responsibilities.medicinal product advertising and promotion (#) - EU Directive 2001/83/ECSix (6) basic principles in EU Directive 2001/83/EC - 1. medicines without a marketauthorisation shall not be advertised2. no off-label indications advertising3. advertising of a medicine must comply withthe specifics in the summary of product char-acteristics (SmPC)4. advertising of a medicine shall encourage therational use of the product by an objective pre-sentation and shall not be misleading5. prescription medicines may only be advertisedto HCPs with the qualifications to prescribe orPreview Mode
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