EU device database, Eudamed, set to become a reality

On 29 October 2009 Member States voted on the first compulsory European database for medical devices, the infamous 'Eudamed' database. The official decision will come into effect once the Commission publishes the legislation in the ‘Official Journal’ - a process that may take some weeks or even months....   czytaj dalej 

Phthalates under the revised Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC.

Eucomed publishes guidance on the requirements of the revised Medical Devices Directive concerning phthalates and a recommendation document on the symbol(s) to be used to promote a harmonized approach to the new labelling requirement. ...   czytaj dalej