Manufacturers are often reluctant to file vigilance reports with Competent Authorities because doing so may be construed as an implicit admission of guilt. In fact, the opposite is true; filing a vigilance report will not result in regulators automatically concluding that the medical device in question caused or contributed to an incident.
Still, according to the European Commission and European Competent Authorities, medical device vigilance reporting remains at a level where underreporting is assumed to still be widespread. It is a confusing subject for many manufacturers active in European markets. There is a European guidance (MEDDEV 2.12/1) document on the topic which has been revised many times over the years. In this whitepaper, we’ll discuss which types of incidents must be reported to Competent Authorities and which do not.
Topics covered in this white paper:
Evangeline Loh, Ph.D., is Vice President of Global Regulatory Affairs at Emergo Group.