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.

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.