Medical device CE marking

The ‘new’ Blue Guide

2014-04

The Guide to the implementation of directives based on the New Approach and the
Global Approach (the “Blue Guide”) was published in 2000. Since then, it has become
one of the main reference documents explaining how to implement the legislation
based on the New Approach, now covered by the New Legislative Framework.

Much of the 2000 edition of the “Blue Guide” is still valid but it requires updating to
cover new developments and to ensure the broadest possible common understanding
on implementation of the New Legislative Framework (NLF) for the marketing of
products. It is also necessary to take account of the changes introduced by the
Lisbon Treaty (in force since 1st December 2009) with regard to the legal references
and terminology applicable to EU-related documents, procedures, etc.

This new version of the Guide will therefore build on the past edition, but include new
chapters, for example on the obligations of economic operators or accreditation, or
completely revised chapters such as those on standardisation or market surveillance.
The Guide has also been given a new title reflecting the fact that the New Legislative
Framework is likely to be used, at least in part, by all types of Union harmonisation
legislation and not only by the so-called “New Approach” directives.

Source: http://ec.europa.eu/enterprise/policies/single-market-goods/documents/internal-market-for-products/new-legislative-framework/index_en.htm#h2-3

 

New guidance on Software

2013-12

A final document has been released on December 9, 2013 by the International Medical Device Regulators Forum (IMDRF) Software as a Medical Device (SaMD).

This document contains various key definitions which focus on a common definition for when software is considered to be a medical device and a reminder of other key terms.

The document may also be downloaded in our library.