MEDIMARK EUROPE

Today few countries in EU allow the reprocessing of single use medical devices and have developed guidelines (e.g. Germany), while some countries prohibit it (e.g. France).The new “Article 12a of the Directive 93/42/EEC such as amended by Directive 2007/47/EC requested that the Commission shall, no later than 5 September 2010, submit a report to the European Parliament and to the Council on the issue of the reprocessing of medical devices in the Community.This report has been published end of August and represents an assessment of the issue regarding public health, ethical, legal, economic and environmental aspects. It includes the scientific opinion of the Committee on Emerging and Newly Identified Health Risks (SCENIHR) concerning the safety of reprocessed medical devices marketed for single useLet’s have a look at the main findings: