Medical Devices

The legal framework of our device vigilance services for medical devices marketed within the EU is provided in Council Directive 93/42/EEC, Council Directive 90/385/EEC, Council Directive 98/79/EC and eventually in Regulation (EU) 2017/745, Regulation (EU) 2017/746, MDCG endorsed documents, MEDDEV guidelines 2.12-1 and 2.12/2 as well as applicable Consensus Statements and Informative Documents. Furthermore, the guidance GHTF SG2 N54 and national legislation build up the framework for the conduct of our device vigilance business.