Harmonised Standards – IVDR

A harmonised standard is a European standard developed by a recognised European Standards Organisation: CEN, CENELEC, or ETSI. It is created following a request from the European Commission to one of these organisations. Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation.

Below you can download the published Harmonise Standards that are relevant for In Vitro Diagnostic Medical Devices in the European Union.

Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council

Publication date: July 2021

Amendment of 6 January 2022 to Implementing Decision (EU) 2021/1195

Publication date: January 2022

Amendment of 11 May 2022 to Implementing Decision (EU) 2021/1195

Publication date: May 2022

Amendment of 4 July 2023 to Implementing Decision (EU) 2021/1195

Publication date: July 2023