European MDR Links
- EU Medical Device Regulation (EU)2017/745 (MDR) EU-Commission pdf
- EU Regulation "Electronic Labelling of Medical Devices" (EU) No 207/2012 EU Commission pdf
- The entire LIST OF GUIDANCE DOCUMENTS published by the European Commission can be found on the "DOCS ROOM".
European MDD Links
- EC-Directive 93/42/EWG (MDD) EU-Commission pdf
- Commission Recommendation
(2013/473/EU)
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
- NBOG Notified Body Operations Group
- CAMD Competent Authorities for medical devices
- NANDO New Approach Notified and Designated Organisations web site
- Team-NB The European Association of Notified bodies for Medical devices
- Scientific Committee on medicinal Products and Medical Devices
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
- Health Canada Guidance Documents
-
Health Canada MDEL
(Establishment license database) -
Heath Canada MDALL
(Device license database)
South America Links
- Brazil INMETRO
- ANVISA Database Registered devices
Eurasian Links
- Link to the EAEU Commission documents, will follow shortly
Other Links
German Links
- Antworten und Beschlüsse EK Med ZLG
- Medizinprodukte-Gesetz MPG Juris
- Medizinprodukte Betreiber Verordnung Juris
-
Der Gesetzesentwurf für den Nachfolger des Medizinprodukte Gesetzes MPG wurde jetzt als "Medizinprodukte-Durchführungsgesetz" (MPDG) vorgelegt,Referentenentwurf des MPG Nachfolgers veröffentlicht)
Das MDPG ist Teil eines "Omnibus-Gesetzes" dem MPEUAnpG (Medizinprodukte Anpassungsgesetz), in dem alle anfallenden Änderungen von bestehenden Gesetzgebungen sozusagen "mitgenommen" werden.
| Content of this website was last updated 2019-10-22 |