The changing face of medical device vigilance & market surveillance in the EU
This article was originally published in Clinica
A great deal is changing in terms of vigilance and post-market surveillance at EU member state level, and even globally, to ensure that there is more transparency for all involved in the reporting and analysing of incidents or near-incidents with medical devices. The result is an increasingly watertight system, reports Amanda Maxwell
You may also be interested in...
Previous businesses FDA warned about COVID-19 claims for chlorine dioxide, a bleach solution, were marketing dietary supplements unlawfully. But Pro Breath MD's oral rinses available under the Dentist Select and OraCare brands are allowed and FDA isn’t asking the firm to discontinue distribution.
The Stark Law ban on self-referrals wouldn’t apply to some physician owners of advanced imaging facilities under a CMS final rule.
Pfizer’s abrocitinib and Biogen/Eisai’s aducanumab are among a host of new investigational products that are under review by the European Medicines Agency.