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- W2524991325 abstract "O 26 September 2012, the European Commission adopted a package on innovation in health consisting of • the Communication on safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals • the Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 • the Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices This presentation will focus on the updates introduced by this proposal and the possible effect it could have on manufacturers in the EU. Topics covered will include: 1. What is the new regulation about? 2. The need and background for the update (including issues such as non-harmonized interpretation and implementation in Member States, issues related to traceability, access to information, clinical evidence and transparency). 3. Expected Benefits (patients, healthcare professionals, manufacturers). 4. What exactly will change (Wider, clearer scope for EU legislation on medical devices, Eudamed database, Better traceability, clinical evidence, Updated classification rules and Better Coordination). 5. Timeline for implementation. Salma Michor, Pharmaceut Reg Affairs 2013 http://dx.doi.org/10.4172/2167-7689.S1.012" @default.
- W2524991325 created "2016-10-07" @default.
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- W2524991325 date "2013-12-03" @default.
- W2524991325 modified "2023-09-28" @default.
- W2524991325 title "The new proposal for a regulation on medical devices in the EU - What to expect?" @default.
- W2524991325 hasPublicationYear "2013" @default.
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