EMERGO BY UL关键点摘要：
EMERGO BY UL关键点摘要：
The European Commission has published an unofficial version of its new regulatory requirements for Notified Bodies that play a key role in CE Mark certification for medical devices.
Although the published requirements contain no reference numbers or dates, the document likely provides a clear indication of how Notified Bodies will have to comply.
Results from a recent survey by European medical technology trade group Eucomed suggest that medical device companies operating in the European Union may face compliance cost increases of up to € 17.5 billion through 2020 depending on whether a centralized premarket authorization system proposed as part of Medical Devices Directives revisions (draft Regulation) becomes law.
A new European Union regulation covering medical devices that use animal tissues has gone into effect starting August 29, 2013.
EU Regulation 722/2012 requires device manufacturers whose products utilize tissues of animal origin to ensure adequate risk management and controls to prevent spreading certain animal-borne diseases to users of their products. The regulation also requires affected manufacturers to conduct specific risk analysis and management procedures prior to submitting conformity assessment applications under the Medical Devices Directive or Active Implantable Medical Devices Directive.
A new survey conducted by The European Association for Medical Devices of Notified Bodies (Team NB) has found a drop in total number of CE Mark certificates issued from 2010 to 2012.
The 2012 survey queried 28 Notified Bodies compared to 19 in a previous survey conducted in 2010.
The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK medical device market regulator, has set up an “innovation office” in an effort to provide a more efficient market authorization process for manufacturers of cutting-edge products.