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 on medical device advertising - 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 differences between EU Member State national rules on medicinal product promotion versus the EU Directive - Some Member States have implemented processes for preapproval of promotional material in their local market surveillance regulations. the impact and aims of international and European codes of conduct and their implementation into national codes of conduct via trade associations (PLACEHOLDER) - Blue Guide - The guide to the implementation of directives based on the New Approach and the Global Approach from 2000. Gives a detailed description of New Approach and Global Approach directives Although not formal law, the ___ ___ has influenced national laws on clinical research throughout the world deeply, including Europe, and continues to do so. - Helsinki Declaration SmPC - A document describing the properties and the officially approved conditions of use of a medicine. Summaries of product characteristics form the basis of information for healthcare professionals on how to use the medicine safely and effectively