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RAC Devices Prep Exam Updated 2024 (EU) Rated A+ 1990s, New Approach (impact on MDs) - EU regulations relating to medical devices' safety and performance were harmonised in the ____(date) _, following the _____ _____ legislative principles. AIMDD (# and date) - Council Directive 90/385/ EEC, 20 June 1990 MDD (# and date) - Council Directive 93/42/EEC, 14 June 1993 IVDD (# and date) - 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 - 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 (#) - EU Directive 2001/83/EC Six (6) basic principles in EU Directive 2001/83/EC - 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 characteristics (SmPC) 4. advertising of a medicine shall encourage the rational use of the product by an objective presentation 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 general public, subject to certain rules. EU's current position