2017/745
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
According to Article 8 (Use of harmonised standards) of the Regulation on Medical Devices:
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.
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.
This web page provides you with updated information on the European standard supporting the implementation of EU Directives and regulations. It provides, on one hand the information corresponding to the real-time status of the standards provided by CEN and CENELEC and, on the other hand, provides updated information about the status of the standards in support of the European legislation. It may happen that a standard is withdrawn by the standardisation body and remains applicable in the context of the EU legislation, unless the reference is withdrawn from the official journal.
"DISCLAIMER: This is an informative page, providing added value information on standards. Information may evolve and change subject to the publication of other legislative texts. This page has no legal validity and only informative value. Genorma.com informs its users that users of this platform are responsible for deciding the version of the standard that is applicable to their products, and not Genorma.com. As a consequence, Genorma.com users are encouraged to check the latest versions of the legal text accessible through the EUR-LEX website or the Website of the European Commission"
102 - Draft standards 81 - View all published standards related to this directive 0 - Withdrawn standards