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The United States has asked the European Union to push back the compliance deadline for the new EU MDR requirements by three years, citing concerns that the world will lose access to the EU’s $125 million medical device market.
Topics: EU Device Regulations, MDRs
For over 20 years, manufacturers have submitted post-market medical device reports (MDRs) to the FDA in a hard copy via the mail. In 2008, the FDA starting allowing reports to be submitted electronically on a voluntary basis. In August 2009, the FDA drafted a guidance for electronic submissions of MDRs. Comments were accepted on this guidance until November 2009. On February 14, 2014, the Final Rule for this guidance was published which goes into effect August 14, 2015.
Topics: Medical Device Reporting, MDRs, 21 CFR 803, FDA