Danish notified body DGM seeks MRA (mutual recognition agreement) CAB (conformity assessment body) status:
This article was originally published in Clinica
Charlottenlund-based DGM has applied to become a conformity assessment body (CAB) under the EU/US mutual recognition agreement (MRA). The company, a notified body (NB) with DANAK (Danish accreditation) in accordance with EN 45001 and 45012, has CE-marking authority for device and diagnostics under relevant EU Directives, 93/42 and 98/79, respectively. Several EU NBs are interested in becoming CABs (see Clinica No 1002, p 1). DGM's auditors have undertaken the necessary training and now await only the FDA's approval.