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View Full Version : The status of the 2005 ammendments to the MDD (Medical Device Directive)? chris1price 23rd July 2007, 06:23 AM Hi All Does anyone know the status of the 2005 ammendments to the MDD? When will they become effective and will there be a transition period? harry 23rd July 2007, 09:57 PM Is the attached document what you are looking for? Ajit Basrur 23rd July 2007, 10:33 PM The latest news on this was that the commission launched the much awaited revision on 22 Dec 2005 - http://europa.eu/rapid/pressReleasesAction.do?reference=IP/05/1684&type=HTML&aged=0&language=EN&guiLanguage=en The Commission proposal was to be forwarded to the European Parliament and Council for co-decision. chris1price 24th July 2007, 05:08 AM Thanks guys, I knew about the reclassification of orthopaedic implants. It was the more complete overhaul I was intested in. The attached file shows all the ammendments. http://ec.europa.eu/enterprise/medical_devices/consult_docs/Public_Consultation_draft.pdf There is a lot of subtle changes in here that we need to be aware of. eg software and clinical trials. These are relevant to me but other people may pick out more points of interest. If anyone hears a date for adoption, can they post it. wrodnigg 9th August 2007, 05:23 AM The revision of the MDD has passed the European Parliament on March 29. 2007. I am awating the publishing of the new directive in the EU-Journal since a couple of weeks (ist should be published this or next month). The directive has to be translated into 25 languages, reviewed and so on... this process takes time... I you are interested, I could look for the parliamental text... ~ghw |
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