Mar 14, 2012

The start of 2012 brings substantial news in the world of European guidance (MEDDEV) documents and one regulation. The European Medical Device Expert Group (MDEG) has released four revised MEDDEVs while adding three brand new MEDDEV documents to the EU Commission Web site, plus a guidance document on standalone software devices. These guidance documents represent EU consensus positions on a multitude of topics, though are not legally binding.

A brief discussion on the major changes follows with further resources below.

E-labeling regulations (Regulation (EU) No. 207/2012)have been published in the Official Journal of the European Union, outlining how Instructions for Use for certain medical devices under the MDD and AIMDD may be provided electronically to professional users. Provision of such users with electronic IFU will require manufacturers to perform an additional risk assessment, taking into account the unavailability of the internet and back-up mechanisms. The document defines the applicable types of medical devices as well as the term electronic. (Note a MEDDEV published in 2007 permitted e- labeling for certain IVDs.)

Changes in the vigilance guidance are introduced by the seventh revision of MEDDEV 2.12/1, Rev. 07 - Guidelines on a Medical Devices Vigilance System. Although not as dramatic as Revision 4 to 5, the revision adds Report Forms for Periodic Summary Reporting (PSR) and Trend Reporting as well as additional examples and clarifications.

The new MEDDEV 2.5/10, - Guideline for Authorized Representatives (AR) has been released. Emergo Group contributed to this document which provides guidance on the role and responsibilities of manufacturer’s AR. (The AR is required when the manufacturer is not established in the EU.)

MEDDEV 2.14/1, Rev. 2 – IVD Medical Device Borderline and Classification Issueshas been expanded to resemble MEDDEV 2.4.1, Rev. 9 and the guidance on medical device classification. The guidance is now 17 pages, and of particular importance may be the discussion on general laboratory use products.

The new MEDDEV 2.1/6 - Guidelines on Qualification and Classification of Stand Alone Software provides criteria and decision diagrams to facilitate classification of standalone software under one of the Directives.

To read the full documents, please visit Emergo Group’s web site:

Lastly, the EU medical device directives are poised for revision. As a reflection of the EU’s commitment to the revision of the existing medical device legislation, a draft document (regulation) is expected in fall 2012.


  • Stewart Eisenhart