Regulatory updates affecting medical device and IVD manufacturers

Have an interest in international regulatory and quality assurance issues? Subscribe to our periodic eJournal. See samples of past eJournal newsletters below:

• SEPTEMBER 2008 - US FDA announces change to registration process
• JUNE 2008 - Updated EN980:2008 standard for Medical Device Labeling released
  
• MAY 2008 - European borderline classification issues
  
• MARCH 2008 - Proposed Changes to the GHTF Regulatory Auditing Guideline
• OCTOBER 2007 - FDA revises user fees for 2008-2012
• OCTOBER 2007 - Upcoming Changes to the European Medical Device Directive
• SEPTEMBER 2007 - Amendments to the European Medical Device Directives published.
• JUNE 2007 - EU issues guidance document on medical device post market surveillance and vigilance
• APRIL 2007 - Hip, knee and shoulder reclassification
• FEBRUARY 2007 - Bulgaria and Romania admission to the EU and impact for medical device manufacturers.
• JANUARY 2007 - EU releases new guidance document for e-labeling

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