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Hello all,
Does anyone have a flowchart or can refer me to a guidance that helps determine if the proposed changes to a medical device is significant or not in the European Union and if these changes are reportable. The FDA has a similar guidance document but I have not found anything similar for the EU. Thanks in advance for your assistance.
Does anyone have a flowchart or can refer me to a guidance that helps determine if the proposed changes to a medical device is significant or not in the European Union and if these changes are reportable. The FDA has a similar guidance document but I have not found anything similar for the EU. Thanks in advance for your assistance.