Links

Regulation (EU) 2017/746 IVDR 

Regulation (EU) 2017/745 MDR

Harmonised Standards

harmonised standards for IVDR (08.03.2024)

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

References of harmonised standards and of other European standards published in the OJEU

harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746

Guidance

MDCG 

MEDDEV

IMDRF

MDCG endorsed documents and other guidance

Guidance MEDDEVs

International Medical Device Regulators Forum

Other

LinkedIn 

EVS Standard

Algemene voorwaarden (Dutch)

https://www.linkedin.com/in/arnold-catsburg/

Estonian centre for standardisation and accreditation (affordable ISO standards)

Algemene voorwaarden 240308