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.
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