EU 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
- Die komplette Liste der Guidance Dokumente der EU Kommission: LIST OF GUIDANCE DOCUMENTS aus dem "DOCS ROOM".
EU 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
EU Organisationen
- 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
Internationale 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
Nordamerika Links
- Health Canada Guidance Documents
-
Health Canada MDEL
(Establishment license database) -
Heath Canada MDALL
(Device license database)
Südamerica Links
- Brazil INMETRO
- ANVISA Database Registered devices
Eurasien Links
- Link to the EAEU Commission documents, will follow shortly
Andere Links
Deutsche Links
- Antworten und Beschlüsse EK Med ZLG
- Medizinprodukte-Gesetz MPG Juris
- Medizinprodukte Betreiber Verordnung Juris
- Referentenentwurf für das
"Medizinprodukte-Anpassungsgesetz-EU – MPAnpG-EU
Mit diesem MPAnpG-EU wird das erstmals das "Medizinprodukte Durchführungs Gesetz (MDG)" dargestellt
| Content of this website was last updated 2019-10-22 |