MDR - Chapter II - article 8
Original text
Expert opinion
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 first subparagraph shall also apply to system or process requirements to be fulfilled in accordance with this Regulation by economic operators or sponsors, including those relating to quality management systems, risk management, post-market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-up (‘PMCF’). References in this Regulation to harmonised standards shall be understood as meaning harmonised standards the references of which have been published in the Official Journal of the European Union.
Use of harmonised standards
This article requires the use of harmonised standards and subsequently, a discussion of their applicability in parts or in whole.
Using such standards is assumed compliant to the MDR 2017/745. Please be adviced that EN standards are EU harmonised standards and have to be primarily used. These standards sometimes are adopted or accepted as consensus standards in other jursidictions, e.g. by the U.S. FDA.
The best practice is to list all applicable standards (in an applicable standards list, short ASL) and discuss their partial or entire applicability. For product development with a multi-jurisdiction focus, you might even find it helpful to mark whether the used standard is accepted by either adoption or consensus in other jurisdiction and extend the list with jurisdiction-specific harmonised standards.
2. References in this Regulation to harmonised standards shall also include the monographs of the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia, in particular on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, provided that references to those monographs have been published in the Official Journal of the European Union
The best practice is, in addition to international harmonised standards, to list guidelines and monographs of the respective Pharmacopoeias.
