New publications in the OJEU of references of harmonised standards in support of the MDR and IVDR
New publications in the OJEU of references of harmonised standards in support of the MDR and IVDR
On 8 March 2024, two Commission Implemented Decisions were published in the Official Journal of the European Union (OJEU) with new references of harmonised standards in support of Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). There are now 25 references of harmonised standards under the MDR and 13 under the IVDR to confer presumption of conformity with the requirements the standards aim to cover.
