(EU) 2017/745
(EU) 2017/746
Archives: Downloads
Obligations for authorised representatives, importers and distributors (CH)
1907/2006 (2024-12) REACH
Registration, Evaluation, Authorisation and Restriction of Chemicals
1999/45/EC, 793/93, 1488/94, 76/769/EEC, 91/155/EEC, 93/67/EEC, 93/105/EC, 2000/21/EC
Registratie en beoordeling van en de autorisatie en beperkingen ten aanzien van chemische stoffen
MDCG 2022-3 Verification of manufactured class D IVDs by notified bodies – Revision 1
IVDR
Factsheet for healthcare professionals and health institutions
Factsheet for Procurement Ecosystem of medical devices and in vitro diagnostic medical devices
Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices
MDR Certification Process – Consensus document
Pre-application
Application
Post Application
2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation – Rev.1
MDCG
MDCG 2024-16 Manufacturer Information Form Art 10a MDR IVDR incl Annex
(EU) 2017/745
(EU) 2017/746
(EU) 2024/1860
Device Identification Table
UDI-DI
EUDAMED