European MDR Links

European MDD Links

  • EC-Directive 93/42/EWG     (MDD)  EU-Commission pdf
  • Commission Recommendation
    on the audits and assessments performed by notified bodies in the field of medical devices pdf
  • EC-Directive 2007/47/EG  (Modification of MDD and AIMD)   EU-Kommission pdf 
  • EG-Directive 2005/50/EG (Re-Classification Joint Replacements)   EU-Commission
  • EC-Directive 2003/12/EG (Re-Classification Brest implants)   EU-Commission

European Organisations


International Links

  • International Medical Device Regulatory Forum, see IMDRF
  • nIVD(MA)ToC
  • GHTF SG1 "Pre-market" Documents , see IMDRF
  • GHTF SG2 "Post market / Vigilance" Documents, see IMDRF
  • GHTF SG3 "Quality Systems" Documents, see IMDRF
  • GHTF SG4 "Auditing" Documents, see IMDRF
  • GHTF SG5 "Clinical safety/Performance" Documents, see IMDRF

North America Links

Asian Links

South America Links

  • Brazil INMETRO
  • ANVISA Database Registered devices

Eurasian Links

  • Link to the EAEU Commission documents, will follow shortly

Other Links

German Links

Content of this website was last updated 2019-10-22