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Legal implications of new interventional devices and procedures

Department of Radiology, Royal Shrewsbury Hospital NHS Trust, Mytton Oak Road, Shrewsbury SY3 8XQ, UK

Summary

• The regulations for the introduction of new medical devices are now standardized across the European Community.
  
• Before a new medical device can be marketed it must obtain a CE Mark.
  
• A medical device that does not have a CE Mark may only be used as part of a scientifically designed trial that has the approval of the MDA.
  
• Permission for such a trial must be obtained from the Local Medical Ethics Committee.
  
• New and unproven interventional procedures should be registered in the UK with the Safety and Efficacy Register for New Interventional Procedures (SERNIP).
  
• Compliance with the advice of SERNIP remains voluntary, but interventional radiologists are strongly advised to observe its recommendations.