EUOJ – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Sun, 12 Jun 2022 18:13:15 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png EUOJ – Eisner Safety Consultants https://eisnersafety.com 32 32 How to Access EU Harmonized Standards List for Medical Based Directives (Non-HTML) https://eisnersafety.com/2020/06/17/access-eu-harmonized-standards-list-medical-directives-non-html/?utm_source=rss&utm_medium=rss&utm_campaign=access-eu-harmonized-standards-list-medical-directives-non-html Wed, 17 Jun 2020 04:30:16 +0000 https://eisnersafety.com/?p=6725 Just found out that the HTML listing of the Harmonized Standards listings are not available anymore. Not that they have been up to date of late anyway but still I refer to them a lot. So, when you search for Harmonized Standards you won’t see the results the way you are used to them.

What to do? No worries! You just need to know where and how to look for them. Easy as 1, 2, 3!!!

First, go to the Harmonized Standards website to pick the applicable Directive as you have in the past.

Next, select the applicable Directive which I will use the MDD for this example. Click on the link near the bottom of the page just below the box that says “Publication in the Offical Journal”, as noted below.

Finally, you end up on the list of Harmonized Standards that are published in the Official Journal of the EU. This was the intention of the EU Commission. I asked an associate at the Commission recently what happened to the easy to use HTML listings on the Directives webpages and his response was “Maybe you were looking for the list in html format, but they are no longer published in that format on the sectorial standardisation pages, to prevent any possible discrepancy and confusion with the lists as published in the OJEU, which are the sole valid lists by a legal point of view.” So, there you have it. The OJEU list in pdf or HTML (but the formatting is horrible) can be accessed. I would stick with the download of the pdf version or the OJ version which in this case has the 3 Directives (MDD, AIMDD, & IVDD) altogether, in the language of your choice.

MDD Harmonized List of Standards Published in the OJEU on 24 March 2020

Need help with identifying “State of the Art” Standards for the Medical Device Regulation (as no Harmonized Standards exist yet for the MDR) or for other country requirements. Leo is on many of the standards writing committees including the IEC 60601 series, ISO 15223-1, AAMI CR 507 & COVID-19 Response Team, & CB Scheme ETF-3 Risk Management Group. Feel free to schedule a call with Leo www.EisnerSafety.com/Schedule-Call/ or contact Leo at Leo@EisnerSafety.com.

]]> It’s Official Finally – The Electronic EU Official Journal https://eisnersafety.com/2013/04/30/its-official-finally-the-electronic-eu-official-journal/?utm_source=rss&utm_medium=rss&utm_campaign=its-official-finally-the-electronic-eu-official-journal Tue, 30 Apr 2013 22:37:53 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=3298 On 7 March 2013 the EU released the Regulation on the electronic publication of the Official Journal of the European Union.  This regulation states that “The Official Journal shall be published in electronic form”, which unofficially it has been accessible for quite a long time, “in the official languages of the…European Union.”  Currently there are 23 languages used in the EU.  The Official Journal is similar to the Federal Register that is published in the US.  The printed version of the Official Journal has been the only legally binding version of EU law until the recent release of this Regulation.  The logistics for the printing and distribution of the daily edition must be a logistical nightmare to be in so many languages and in a very timely manner too.  Being the EU is so environmentally conscious it is surprising it took so long to get to this point.

The Regulation states that “only the Official Journal published in electronic form…shall be authentic and shall produce legal effects.”  What is nice about this Regulation is they are making access to the Official journal free to all that want to use it and that it won’t become obsolete either as the Regulation states: “The electronic edition of the Official Journal shall be made available to the public on the EUR-Lex website in a non-obsolete format and for an unlimited period.  Its consultation shall be free of charge.”  The Regulation is anticipated to take effect around July 2013.

You can access the Regulation on the electronic publication of the Official Journal of the European Union here.

To access the electronic version of the Official Journal on the Euro-lex website (part of the europa website) choose this link to see EU law. 

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