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:
- JUNE 2009 - EU issues guidance on 2007/47/EC for companies selling in Europe
- APRIL 2009 - US FDA issues notice about Class III preamendment devices
- MARCH 2009 - New regulation for devices with an electrical component sold in Ontario, Canada
- FEBRUARY 2009 - New European guidance documents on clinical data
- 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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