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CE Mark

欧盟委员会针对企业在英国无协议脱欧情况下营销医疗器械的要求

EMERGO BY UL关键点摘要:

  • 与经济所有权相关的“投放市场”的定义;
  • 经济所有权仅适用于已经生产的商品;
  • 英国脱欧日之后,英国公告机构的CE标志证书将会失效;
  • 就证书而言,没有针对医疗器械的例外。

"Unofficial" NB Inspection Requirements Published by European Commission

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.

Industry Survey: Revised EU Medical Device Directives could Cost Firms € 18 Billion

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.

New EU Animal Tissue Regulations in Effect for Some Medical Devices

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.

Team NB Survey: CE Marking Certificates for Medical Devices Decreased in 2012

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.