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 com 2012 542 194 pages in english french spanish and other official eu languages. this proposal for a regulation of the european parliament and of the council on medical devices aims at revising the eu regulatory framework for medical devices. the scope of the eu legislation will be clarified and extended e.g. implants for aesthetic purposes products manufactured utilising non-viable human tissues or cells . supervision of the independent conformity assessment bodies so called notified bodies by the member states will be strengthened to ensure that all bodies have the necessary competence to carry out the pre-market assessment of medical devices. the conformity assessment procedures are streamlined and the position and powers of notified bodies vis-a-vis the manufacturers will be enhanced ensuring thorough tests and regular checks including unannounced factory inspections. economic operators e.g. manufacturers importers distributors will be subject to clearer obligations and responsibilities including those in the field of diagnostic services and internet sales. the european database on medical devices eudamed will be further developed to provide comprehensive information regarding medical devices on the eu market. non-confidential data will be publicly available. the proposal sets the basis for a european unique device identification udi system to allow traceability of medical devices. rules concerning clinical investigations on medical devices and the required clinical data for the pre-market and the continuous post-market assessment of medical devices will be reinforced. the classification rules that divide the broad scope of medical devices into four different risk classes as well as the essential health and safety requirements including labelling provisions are adapted to technological and scientific progress. coordination between national competent authorities will be improved in particular in the field of market surveillance with the european commission providing the necessary scientific technical and administrative support. relevant guidelines developed by the global harmonization task force ghtf will be incorporated into eu law with a view to converging the regulatory requirements for medical devices in major economies. the proposal after being adopted will replace the existing medical devices directives i.e. council directive 90 385 eec and council directive 93 42 eec. another proposal has been adopted for a regulation of the european parliament and of the council on in vitro diagnostic medical devices which is subject to a separate notification.