Medical device CE marking

RoHS 2 applicable for Medical Devices per 22 July 2014


RoHS 2 is an update to the European Directive 2002/95/EC that limits the use of certain specified hazardous substances to be placed on the EU market from 1st January 2006. The new RoHS Directive 2011/65/EU (RoHS 2) became effective on 3 January 2013. RoHS 2 deals with the same hazardous substances and the same maximum concentration limits as Directive 2002/95/EC (RoHS 1).

The Directive shall apply to medical devices which are placed on the market from 22 July 2014. There is an extended transition period for in vitro diagnostic (IVD) equipment (until 22 July 2016).

Those affected by this Directive are producers of Electrical and Electronic Equipment (known as EEE). They must ensure that their products and the components of such products comply with the requirements of the Directive.

New / updated harmonized standards


On May 16, 2014 the EU Commission has published some new / updated harmonized standards for the 93/42/EEC (MDD).

Product, which conform to harmonized standards, are presumed to comply with the essential requirements in the Medical Device Directives.

The updates of horizontal standards, include a.o.:

Ref. Desription In force:
EN ISO 11137-1:2006/A1:2013 Sterilization of health care products – Radiation 2014-11-30
EN ISO 11137-2:2013 Sterilization of health care products – Radiation 2014-11-30
EN ISO 13408-1:2011/A1:2013 Aseptic processing of health care products 2014-11-30
EN 60601-1:2006/A1:2013 Medical electrical equipment 2017-12-31

All harmonized standards you find here:

Medical Devices

In vitro diagnostic Medical Devices

Active Implantable Medical Devices

The ‘new’ Blue Guide


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.



New guidance on Software


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.