European Documents

 

  • 2013/473/EU: Commission Recommendation of 24 September 2013  EU Commission pdf
  • EU Regulation "Electronic Labelling of Medical Devices" (EU) No 207/2012 EU Commission 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

German Documents

  • Antworten und Beschlüsse EK Med   ZLG
  • Medizinprodukte-Gesetz MPG   Juris
  • Medizinprodukte Betreiber Verordnung  Juris

International Documents

 

  • International Medical Device Regulatory Forum, see IMDRF
  • 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

 

Asian Documents

 

  • AHWP Documents è   AHWP

Eurasian Documents

  • Link to the EAEU Commission documents, will follow shortly