Competent Authority/-ies (CA)
Agency for data protection
MD CE-marked, use outside label
MD CE-marked, use outside label + IMP
MD without label
MD without label + IMP
Clinical investigations of CE marked devices utilised for their intended purpose do require notification to EC only!
NB! Combination studies: If the investigation includes an evaluation of medicinal products, the clinical investigation may be classified as a clinical trial of medicinal products and require authorisation by the DHMA unit for clinical trials