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. 

On 15 Jan ’13 the FDA issued a notice in Federal Register for the Recognition List # 30.  The notice in the Federal Register said: “FDA maintains the Agency’s current list of FDA recognized consensus standards in a searchable database…FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary.”

Other resources that you can find out more about this subject:

RAPS Regulatory Focus article of 15 Jan 2013

CDRH’s Standards Program / Standards Management Staff webpage

 On 24 Jan ’13 the Official Journal of the European Union published updated lists of Harmonized Standards under their respective Directives for the:

MDD (OJ published updated list of Harmonized Standards) and the consolidated list of Harmonized Standards*

AIMDD (OJ published updated list of Harmonized Standards) and the consolidated list of Harmonized Standards*

IVDD (OJ published updated list of Harmonized Standards) and the consolidated list of Harmonized Standards*

* – All of the consolidated lists of Harmonized Standards have a note that indicate that these are for reference only and are not the legal documents.  A repeat of the note for these Directives is below:

“The summary list hereunder is a compilation of the references of harmonised standards which have been generated by the HAS (Harmonised standards) database. This IT application HAS automates the process of the publication of the references of harmonised standards in the Official Journal of the European Union. Although the list is updated regularly, it may not be complete and it does not have any legal validity; only publication in the Official Journal gives legal affect.”

The post on this Commission Regulation (EU) No 722/2012 is thx to Erik Vollebregt who blogs on EU legal and regulatory developments of medical devices.  Erik has provided content previously to our blog and we thank him for his generosity in allowing us to post his content.