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
Generation European Regulations
Regulation (EU) 2017/745 (MDR) consolidated
Regulation (EU) 2017/746 (IVDR)
Corrigendum to Regulation (EU) 2017/745 (MDR)
MDCG (Medical Devices Coordination Group – Documents)
NANDO (New Approach Notified and Designated Organisations)
NAKI (Nationaler Arbeitskreis zur Implementierung der MDR / IVDR)
EU – Medical Devices
CAMD (Competent Authorities for Medical Devices)
Generation European Directives
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
