The Objective is to draft and revise harmonised standards in support of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 and on in vitro diagnostic medical devices
Manufacturers and Notified Bodies looking forward to those standards since they play an important role in regards to the compliance with the MDR/IVDR. Complying with European Harmonized Standards means presumption of conformity with the corresponding legal requirements of the MDR/IVDR. See for example Article 8 MDR:
Article 8
Use of harmonised standards
1. Devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof.
The standardization is major pillar and indeed one of the philosophy of the European CE marking Approach.
Here is the document publication.
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