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May 03, 2021

EU MDR TIPS

TIP # 1: FINDING HARMONIZED STANDARDS
Author: Isabel Osorio, President and Owner of MDR Consultants Inc.

Section 1 of Article 8 of the EU MDR Regulation (EU) 2017/745, with title “Use of harmonized standards”, states:

Devices that are in conformity with the relevant harmonized 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.

It also states under the same section:

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.

This means, that in order for us to be able to use a standard as a method, basis, or mean of
conformance to the EU MDR regulation, we need to ensure that the standard has been
published in the Official Journal of the European union.

So, how can we search for a standard to verify that it is an official harmonized standard?

All harmonised standards are published in the C-series of the Official Journal:
http://eur-lex.europa.eu/JOIndex.do?ihmlang=en

  1. Via the publication reference, directly in the Official Journal.
  2. Or By subject or Directive number, see the index made by the European
    Commission: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en
  3. Or By using the search form on the website of the European Committee for
    Standardisation
    (CEN): https://standards.cen.eu/dyn/www/f?p=CENWEB:105::RESET

Medical devices related harmonized standards published under 93/42/EEC are found in
Commission Implementing Decision (EU) 2020/437 of 24 March 2020 (OJ L 90I, 25 March
2020). The link is provided below. The decision applies until 26 May 2024.

EUR-Lex – L:2020:090I:TOC – EN – EUR-Lex (europa.eu)

Note: All referenced links are provided in the description or the first comment of this post, depending
on the social media platform in which the information is being published.

MDR Consultants Inc.
11111 Biscayne Blvd. Apt. 300, Miami, Florida, 33181
(786) 306-0227
info@mdrconsultants.com | www.mdrconsultants.com

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