Danish and US device certification agreement signed
This article was originally published in Clinica
Executive Summary
Denmark's Notified Body, DGM, the Danish Standards Association (DS) and US Notified Body Underwriters Laboratories have signed a reciprocal device certification agreement. The deal allows DGM to provide Scandinavian manufacturers with information and support on the FDA's 510(k) third-party review programme in which UL evaluates applications and submits a recommendation to the FDA on US marketing.