REGULATORY LINKS – OUR SPECIAL SERVICE FOR YOU
regular services is constantly assembling helpful portals on the topic of Regulatory Affairs.
Click on the desired topic in the respective country and you will be connected to the selected portal.
Europe
Directive 93/42/EEC, consolidated
Directive 90/385/EEC, consolidated
Directive 98/79/EC, consolidated
Offical Journal of the European Union
MEDDEV (Guidance Documents)
Notified Bodies for Medical Device (NB-MED)
Notified Body Operation Group (NBOG)
Harmonized Standards for Direcitve 93/42/EEC
Harmonized Standards for Direcitve 90/385/EEC
Harmonized Standards for Direcitve 98/79/EC
Regulation (EU) 2017/745 (MDR)
Regulation (EU) 2017/746 (IVDR)
