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MDD Harmonized List of Standards Website Moves & Medical Device Sector Page Changes

On 2 Feb 2015 the previous site for the List of Harmonized Standards for the MDD and other Medical Device Directives (AIMDD & IVDD) moved to a new location.

The old MDD Harmonized Standards Listing used to be located at the website address of http://bit.ly/MDD_Harmonized_Stds_Listing but as of 2 Feb 2015 the site has been archived.  The new site can be found by following the instructions on the archived site.  First click on the link in the bright yellow band on the top of the old site titled “Internal Market, Industry, Entrepreneurship and SMEs website“, then on the new page that opens click on the “Single Market and Standards” link, then on the left hand bar select the link titled “European Standards“, then on the next web page select the link on the left hand bar titled “Harmonised Standards“. Then search for the section titled “Healthcare engineering” and select the applicable medical device directive you are looking for:

In addition to the Harmonized List of Standards updated web pages the Medical Devices Home Page (The important links are mostly on the left hand side of the web page) on the Europa website has been updated recently too and there seems to be more info and it appears to be better organized.  I haven’t had time to search thru all of the volumes of info in it.  I think there are a few kinks on this new site as one page I clicked a link and the page would disappear after about 2 seconds on the page and another link I got an error message on the webpage it landed on.  So, it is a much improved site but also expect some bugs hopefully only for a short while.  Let Europa know about the issues at grow-webmaster at ec.europa dot eu so they can get fixed.

If you need help with your EU CE for the Mark Medical Device Directive, the Active Implantable Medical Device Directive or the IVD Directive, email Leo Eisner directly at Leo at EisnerSafety dot com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).